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APSF.ORG NEWSLETTER THE OFFICIAL JOURNAL OF THE ANESTHESIA PATIENT SAFETY FOUNDATION

Volume 35, No. 2, 33–68 More than 1,000,000 readers annually worldwide June 2020 Disclaimer: Viewers of this material should review the information contained within it with appropriate medical and legal counsel and make their own determinations as to relevance to their particular practice setting and compliance with state and federal laws and regulations. The APSF has used its best efforts to provide accurate information. However, this material is provided only for informational purposes and does not constitute medical or legal advice. These articles also should not be construed as representing APSF endorsement or policy (unless otherwise stated), making clinical recommendations, or substituting for the judgment of a physician and consultation with independent legal counsel.

An Update on the Perioperative Considerations for COVID-19 Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) by Liana Zucco, MD; Nadav Levy, MD; Desire Ketchandji, MD; Michael Aziz, MD; and Satya Krishna Ramachandran, MD

INTRODUCTION over 3.1 million people, as of April 29, 2020, with 1,2 The COVID-19 pandemic caused by the over 1 million cases in the United States alone. severe acute respiratory syndrome coronavirus-2 Current estimates suggest a fatality rate (SARS-CoV-2) continues to have a profound ranging from 2 to 20% for hospitalized patients, impact on life across the globe and has placed and up to 88% for those requiring mechanical 3–5 an enormous strain on health care systems and ventilation. SARS-CoV-2 has an estimated basic reproductive number (R0) of 2.2–2.7,6 economies, including with likely untold psycho- which means a single infected person has the logical and social implications. The outbreak of potential to spread infection to more than 2 sus- SARS-CoV-2, which originated in Wuhan, , ceptible individuals. This can lead to rapid, rapidly progressed to become a pandemic and exponential spread, which we have now seen See “COVID-19 Perioperative 7 has now spread to over 150 countries, infecting within communities across the US. Considerations,” Page 35

———————— O R I G I N A L W O R K ———————— COVID-19 Pandemic—Decontamination of Respirators and Masks for the General Public, Health Care Workers, and Hospital Environments by Qisheng Ou, PhD; Chenxing Pei; Seong Chan Kim, PhD; Kumar Belani, MD; Rumi Faizer, MD; John Bischof, PhD; and David Y. H. Pui, PhD

There is a serious shortage of respirators and masks that are essential for the protection of Decontamination of Respirators & Masks for the General Public, Health Care Workers And Hospital Environments frontline health care workers and for the mitiga- tion of community transmission during this COVID-19 pandemic.1 Reuse of disposable filter- 10 Cycles ing facepiece respirators and surgical masks after N95 Decontamination decontamination has become a necessary strat- results in: egy.2,3 We provide here scientific data to support ü Highly the use of three decontamination methods. Surgical UVGI Efficient Mask ü Fit is maintained o 77 C Oven Steam Heat ü Can be used AANA and Other Readers: Procedure up to 10x If you are not on our mailing list, please Mask subscribe at https://www.apsf.org/subscribe 30 min. NOTE: This study only tested unused respirator/mask performance after multiple treatments. Worn respirators/masks may have deterioriation in integrity and and the APSF will send you an email of the efficiency, which cannot be recovered from decontamination. current issue. See “Mask Decontamination” Page 40

TABLE OF CONTENTS, NEXT PAGE APSF NEWSLETTER June 2020 PAGE 34

TABLE OF CONTENTS ARTICLES: NEWSLETTER An Update on the Perioperative Considerations for COVID-19 Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)...... Cover COVID-19 Pandemic—Decontamination of Respirators and Masks for the The Official Journal of the General Public, Health Care Workers, and Hospital Environments...... Cover Anesthesia Patient Safety Foundation Postoperative Recurarization After Sugammadex Administration Due to the Lack of Appropriate Neuromuscular Monitoring: The Japanese Experience...... Page 42 The Anesthesia Patient Safety Foundation Newsletter Effective Leadership and Patient Safety Culture...... Page 44 is the official publication of the nonprofit Anesthesia Misfilling the Exhausted Vaporizer...... Page 46 Patient Safety Foundation and is published three Swaps and Compressed Medical Gases...... Page 47 times per year in Wilmington, Delaware. Individuals When Medical Equipment Standards Fail to Protect Patients...... Page 48 and corporations may subscribe for $100. If multiple copies of the APSF Newsletter are needed, please Cardiopulmonary Sentinel Event During Endoscopic Retrograde Cholangiopancreatography (ERCP): Oversedation or Gas Embolism?...... Page 49 contact: [email protected]. Contributions­ to the Gas Embolism Events in GI Endoscopy: What We Know Now and How We Can Mitigate Them Through Foundation are tax-deductible.­ ©Anesthesia Patient the Routine Use of CO2 Insufflating Gas Instead of Air...... Page 50 Safety Foundation, 2020. Malignant Hyperthermia Preparedness: Stocking, Drilling, and Offsite Considerations...... Page 51 The opinions expressed in this Newsletter are not Educating the Next Generation: A Curriculum for Providing Safe Anesthesia in Office-Based Surgery...... Page 53 necessarily those of the Anesthesia Patient Safety The Anesthesiology Professional’s Role in Stewardship...... Page 58 Foundation. The APSF neither writes nor promul- Safety and Utility of for Labor Analgesia...... Page 60 gates standards, and the opinions expressed herein Successful Evidence-Based International Emergency Manual Implementation Strategy...... Page 62 should not be construed to constitute practice stan- : A Review of an Established Yet Often Underappreciated Medication...... Page 64 dards or practice parameters. Validity of opinions pre- sented, drug dosages, accuracy, and completeness APSF ANNOUNCEMENTS: of content are not guaranteed by the APSF. Guide for Authors...... Page 34 APSF Executive Committee 2019: Get Social With Us!...... Page 48 Mark A. Warner, MD, President, Rochester, MN; Daniel APSF Donor Page...... Page 57 J. Cole, MD, Vice President, Los Angeles, CA; Matthew 2020 APSF Trainee Quality Improvement (TQI) Recognition Program Announcement...... Page 59 B. Weinger, MD, Secretary, Nashville, TN; Douglas A. Bartlett, Treasurer, Boulder, CO; Maria van Pelt, CRNA, NEW 2020 ASA/APSF Quality Improvement Abstract Award Announcement...... Page 59 Crowdfunding Announcement...... Page 59 PhD, Director At-Large, Boston, MA. Legacy Members...... Page 67 APSF Newsletter Editorial Board 2019: 2020 Board Members and Committee Members:...... https://www.apsf.org/about-apsf/board-committees/ Steven B. Greenberg, MD, Editor-in-Chief, Chicago, IL; Edward A. Bittner, MD, PhD, Associate Editor, Boston, and have appropriate referencing (see http://www.apsf.org/ MA; Jennifer M. Banayan, MD, Associate Editor, Chi- Guide for Authors authorguide). The articles should be limited to 2,000 words with cago, IL; Meghan Lane-Fall, MD, Assistant Editor, Phila- The APSF Newsletter is the official journal of the Anesthesia Patient no more than 25 references. Figures and/or tables are strongly delphia, PA; Trygve Armour, MD, Rochester, MN; JW Safety Foundation. It is widely distributed to a variety of anesthesia encouraged. Beard, MD, Wilmette, IL; Heather Colombano, MD, professionals, perioperative providers, key industry representatives, 2. Q&A articles are submitted by readers regarding anesthesia Winston-Salem, NC; Jan Ehrenwerth, MD, New Haven, and risk managers. Therefore, we strongly encourage publication of patient safety questions to knowledgeable experts or desig- CT; John H. Eichhorn, MD, San Jose, CA; Nikolaus Gra- those articles that emphasize and include the multidisciplinary, mul- nated consultants to provide a response. The articles should be venstein, MD, Gainesville, FL; Joshua Lea, CRNA, tiprofessional approach to patient safety. It is published three times limited to 750 words. Boston, MA; Bommy Hong Mershon, MD, Baltimore, a year (February, June, and October). Deadlines for each issue are 3. Letters to the editor are welcome and should be limited to 500 MD; Tricia A. Meyer, PharmD, Temple, TX; Glenn S. as follows: 1) February Issue: November 15th, 2) June Issue: words. Please include references when appropriate. Murphy, MD, Chicago, IL; Brian Thomas, JD, Kansas March 15th, 3) October Issue: July 15th. The content of the news- 4. Rapid Response (to questions from readers), formerly known as, City, MO; Jeffrey S. Vender, MD, Winnetka, IL; Wilson letter typically focuses on anesthesia-related perioperative patient "Dear SIRS," which was the “Safety Information Response Somerville, PhD, Editorial Assistant, Winston-Salem, safety. Decisions regarding content and acceptance of submissions System,” is a column that allows for expeditious communication NC. Please see the links of international editors at for publication are the responsibility of the editors. Some submis- of technology-related safety concerns raised by our readers, with https://www.apsf.org/wp-content/uploads/newsletter/ sions may go in future issues, even if the deadline is met. At the dis- input and response from manufacturers and industry representa- APSF-International-Editors.pdf cretion of the editors, submissions may be considered for tives. Dr. Jeffrey Feldman, current chair of the Committee on publication on our APSF website and social media pages. Address all general, contributor, and sub­scription Technology, oversees the column and coordinates the readers’ correspondence to: Articles submitted that are not in accordance with the following inquiries and the response from industry. instructions may be returned to the author prior to being reviewed 5. Invited conference reports summarize clinically relevant anesthe- Stacey Maxwell, Administrator for publication. sia patient safety topics based on the respective conference Anesthesia Patient Safety Foundation 1. Please include a title page which includes the submission’s title, discussion. Please limit the word count to less than 1000. P.O. Box 6668 authors' full name, affiliations, conflicts of interest statement for Commercial products are not advertised or endorsed by the APSF Rochester, MN 55903, U.S.A. each author, and 3–5 keywords suitable for indexing. Please Newsletter; however, upon exclusive consideration from the edi- [email protected] include word count on the title page (not including references). tors, articles about certain novel and important safety-related tech- 2. Please include a summary of your submissions (3–5 sentences) Address Newsletter editorial comments, questions, nological advances may be published. The authors should have no which can be used on the APSF website as a way to publicize letters, and suggestions to: commercial ties to, or financial interest in, the technology or com- your work. Steven B. Greenberg, MD 3. All submissions should be written in Microsoft Word in Times mercial product. Editor-in-Chief, APSF Newsletter New Roman font, double-spaced, size 12. If accepted for publication, copyright for the accepted article is [email protected] transferred to the APSF. Except for copyright, all other rights such 4. Please include page numbers on the manuscript. Edward A. Bittner, MD, PhD 5. References should adhere to the American Medical Association as for patents, procedures, or processes are retained by the author. Permission to reproduce articles, figures, tables, or content from Associate Editor, APSF Newsletter citation style. [email protected] Example: Prielipp R, Birnbach D. HCA-Infections: Can the anes- the APSF Newsletter must be obtained from the APSF. thesia provider be at fault? APSF Newsletter. 2018; 32: 64–65. Additional information: Jennifer M. Banayan, MD https://www.apsf.org/article/hca-infections-can-the-anesthesia 1. Please use metric units whenever possible. Associate Editor, APSF Newsletter provider-be-at-fault/ Accessed August 13, 2019. 2. Please define all abbreviations. [email protected] 6. References should be included as superscript numbers within 3. Please use generic drug names. Meghan Lane-Fall, MD the manuscript text. 4. Please be aware of HIPAA and avoid using patient names or per- Assistant Editor, APSF Newsletter 7. Please include in your title page if Endnote or another software sonal identifiers. [email protected] 5. Plagiarism is strictly prohibited. tool for references is used in your submission. Send contributions to: Types of articles include (1) Invited review articles, Pro/Con Debates Individuals and/or entities interested in submitting material for and Editorials, (2) Q and As, (3) Letters to the Editor, (4) Rapid publication should contact the Editor-in-chief directly at green- Anesthesia Patient Safety Foundation Response, and (5) Conference reports. [email protected]. Please refer to the APSF Newsletter link: http:// P.O. Box 6668 1. Review articles, invited Pro/Con debates, and Editorials are www.apsf.org/authorguide that will provide detailed information Rochester, MN 55903, U.S.A. ­original manuscripts. They should focus on patient safety issues regarding specific requirements for submissions. Or please donate online at www.apsf.org. APSF NEWSLETTER June 2020 PAGE 35

Lessons Learned from Current and Past Viral Outbreaks

From “COVID-19 Perioperative Considerations,” Cover Page Recommendations for Airway Management Given the capacity for human-to-human trans- in a Patient with Confirmed or Suspected mission,8–10 SARS-CoV-2 continues to pose a www.apsf.org high risk to all health care professionals in the COVID-19 Infection perioperative setting. We implore perioperative YOUR personal protection is THE priority. Personal protective equipment (PPE) should be available for all and hospital leaders to develop strategic steps providers to ensure droplet/contact isolation precautions can be achieved. Review protocols for donning and doffing PPE. Careful attention is required to avoid self-contamination. for interventions on patients who have sus- pected or confirmed COVID-19 infection. The Patients with confirmed or suspected COVID-19 infection: purpose of this communication is to present pru- o Should NOT be brought to holding or PACU areas dent safety measures in the perioperative set- o Should be managed in a designated OR, with signs posted on the doors to minimize staff exposure. ting, recognizing that these measures are based o Should be recovered in the OR or transferred to ICU into a negative pressure room. o Should have a high-quality HME (heat and moisture exchanging) filter, rated to remove at least 99.97% of on learning from the current outbreak as well as airborne particles 0.3 microns or greater, placed between the ETT and circuit/reservoir bag at all times. from previous viral outbreaks.11 Specifically, we address those measures which resulted in the Plan ahead: success or failure of curtailing transmission of o For time to allow all staff to apply PPE and barrier precautions Consider intubation early to avoid the risk of a crash intubation when PPE cannot be applied safely. viral pathogens (SARS-CoV-2, SARS-CoV, and o Middle Eastern Respiratory Syndrome Corona- virus [MERS-CoV]) in health care settings. While During Airway Manipulation nonpharmacological interventions remain the Apply: o PPE: N95 mask (or equivalent), eye protection or a face shield, an impermeable fluid mainstay in curtailing the spread of disease, resistant gown, disposable head cover, protective footwear, and 2 sets of gloves. global experiences highlight the prominent role o Standard ASA monitoring should be applied before induction of anesthesia. of prompt public health measures in combating Assign: a pandemic of this magnitude. o The most experienced anesthesia professional available to perform intubation, if possible. Avoid trainee intubation for sick patients.

SARS-COV-2 PATHOGEN Discuss: TRANSMISSION o The plan for an unanticipated difficult intubation and ensure that desired rescue equipment is immediately available, including a supraglottic airway and a surgical airway kit. Pathogen transmission can occur between humans via inhalation of infected respiratory Avoid: o Awake fiberoptic intubation, unless specifically indicated. Atomized local will droplets, in particular if the exposure of droplets aerosolize the virus. Consider alternate topicalization methods if indicated. is within close proximity (6 feet) or if you are in a relatively closed-off environment with continu- Prepare to: Preoxygenate for 5 minutes with 100% FiO2, or until a desired target EtO2 is achieved. 12,13 o ous exposure to high aerosol counts. Trans- o Use equipment most familiar to the intubator; a video-laryngoscope is recommended as the mission can also occur through close contact, primary intubating device to improve intubation success. either directly or indirectly, with mucous mem- Perform a Rapid Sequence Intubation (RSI): o Perform a RSI to avoid manual ventilation of patient's lungs and potential aerosolization of branes (i.e., eyes, nose, mouth) and through the virus from airways. 12,14 digestive tract. There is now evidence to o Depending on the clinical condition, the RSI may need to be modified. suggest that transmission may occur from o If manual ventilation is required, apply small tidal volumes, ensure an HME filter is in place. o Immediately post intubation, inflate the ETT cuff before applying positive pressure direct or indirect contact with contaminated sur- ventilation faces (fomites) and this may predispose to sub- Ensure: sequent self-inoculation and/or transmission. o A high quality HME filter is in place between the ETT/facemask and breathing Similar to other coronaviruses, SARS-CoV-2 is circuit/reservoir bag at all times able to survive outside the body for approxi- Dispose: mately 12 hours (fabrics, cardboard surfaces) o Resheath the laryngoscope immediately post intubation (double glove technique) or place within sealed bag. Seal all used airway equipment in a double zip-locked plastic bag. It must and up to 72 hours (plastic or metal sur- then be removed for decontamination and disinfection. faces).11,15,16 Extubation: Preventing transmission of the SARS-CoV-2 o Should occur under strict adherence to PPE. Consider the use of a protective cloth barrier to cover the mouth during extubation. Carefully dispose of contaminated equipment. remains the most effective public health effort to lessen its impact. This effort involves rapid Remember: After removing protective equipment, avoid touching hair or face before washing hands. identification of cases, tracing of contacts, isola- o tion/quarantine of infected/exposed individu- Track: o Symptoms of health care providers involved in airway manipulation, consider using an online als, and supportive care. We recognize the registry such as IntubateCOVID at https://intubatecovid.knack.com/registry#add-intubation/ perioperative setting as a site for possible unrecognized exposure to SARS-CoV-2; therefore, hospital-wide guidelines should be Updated May 12, 2020 available for health care professionals to manage exposure and implement measures to mitigate transmission. See “COVID-19 Perioperative Considerations,” Next Page APSF NEWSLETTER June 2020 PAGE 36

Recommendations for COVID-19 Patient Airway Management

From “COVID-19 Perioperative Considerations,” mend a unified approach to supporting and cover, an impermeable fluid-resistant gown, Previous Page communicating with members of staff within shoe covers, and two sets of gloves. Disposable Lessons Learned from Previous Coronavirus your organization. OR caps reduce the risk of contaminating hands Outbreaks (SARS-CoV, MERS) by touching hair which may have been exposed Pathogen Transmission in the OR and Around to droplets. Hand washing is essential before We learned from the Toronto SARS-CoV out- the Anesthesia Work Environment break in 2002 and the MERS-CoV outbreak in donning and after doffing of PPE. Within the operating room (OR), the anesthe- 2012 that the majority of cases were associated sia work environment allows for numerous sur- N95 masks fulfill the filtering efficiency crite- with nosocomial transmission, in particular faces that can harbor droplets, thus serving as ria of the National Institute for Occupational amongst health care workers (HCWs) exposed reservoirs for the virus if proper droplet precau- Safety and Health (NIOSH) and are approved to aerosol-generating procedures.17 Despite tions or proper decontamination processes are for protection against droplet and airborne existing safety protocols, confirmed SARS-CoV not followed. As noted previously, processes transmission of 95% of particles greater than infection of HCWs was associated with the intu- that favor aerosolization of sputum an infected 0.3 microns in size. N95 masks, which must be bation of a confirmed SARS-CoV infected individual in the perioperative setting repre- fit tested, offer protection against the contact patient in the ICU, if more than one attempt at sents a potential source of exposure to HCWs. and droplet spread of the coronavirus. Alterna- intubation was required or when more than For the anesthesia professional and intensivist, tively, a PAPR may be used instead of an N95 three people were in the room.18 Additional risk attention should be given to the time periods respirator. This provides equivalent protection factors included patient contact during aerosol- during intubation and extubation, as these rep- to an N95, but may offer greater versatility for izing procedures including via nebulizers, CPAP, resent the highest risk of exposure and involve use across various face sizes, in the presence BiPAP, or high flow nasal oxygen therapy.11 direct contact with respiratory droplets during of facial hair, or in multiple-use scenarios. Bear However, improved measures and adherence airway management.23,24 in mind that a PAPR may be more cumbersome to PPE reduced nosocomial transmission to don and doff without self-contamination, and during the second wave of the SARS-CoV out- Areas immediately outside the OR and therefore, careful observation by a colleague break in Toronto. More recent data suggest around the operating department complex rep- may mitigate this risk. At a minimum, N95 res- high flow nasal oxygen may not augment aero- resent low-risk areas with regards to aerosol pirators or their equivalent should be used for sol spread during spontaneous coughing in generation, but may still be potential sources all known or suspected cases of COVID-19. healthy volunteers.19 for transmission. Irrespective of location, inad- equate PPE, improper use of PPE, and poor Providers and their organizations should Lessons Learned from the Current Outbreak hand hygiene are potential factors that can lead review protocols for correct donning and doff- (SARS-CoV-2): to transmission to the bedside HCW.25,26 ing of PPE. Consider conducting mock intuba- Experience from China, Italy, the United King- tion/extubation drills using PPE in a real dom, and the United States makes it abun- RECOMMENDATIONS FOR environment (in situ). This is an opportunity to dantly clear that community transmission is THE PERIOPERATIVE PRACTICE OF promote correct use of PPE among providers responsible for the majority of infected patients.1 ANESTHESIA IN PATIENTS and to identify barriers to adherence. Consider- Disease prevalence remains high in various WITH COVID-19 ation at the organization level should be taken parts of the country, with a lack of widely avail- Due to the potential for transmission of SARs- to avoid ‘’rescue like’’ crash intubations where able and reliable testing posing a risk of noso- CoV-2 in asymptomatic patients and HCWs, we PPE cannot be fully adhered to. comial transmission in the perioperative setting. recommend an escalation of standard practice Airway Manipulation (Intubation and Extuba- The period immediately prior to symptom onset during the perioperative management of all tion): is associated with SARS-CoV-2 viral shedding patients to reduce exposure to secretions. and represents a considerable transmission Prior to exposure to an aerosolizing proce- potential, further implicating all (asymptomatic) Hand Hygiene: dure or airway management, HCWs should pro- patients as an additional risk.20,21 To protect and Frequent hand washing is one of the most tect themselves by donning the appropriate ensure the safety of HCWs, and by extension, important hygiene measures to protect against PPE, described above. During intubation and patients, preventing nosocomial transmission cross infection and must be actively enforced. extubation, limit the number of staff members of SARS-CoV-2 requires a coordinated effort -based hand wash gels should be present inside the room to reduce the risk of and complete organizational support.22 located on or near every anesthesia worksta- unnecessary exposure, unless staff members tion. Hand hygiene (HH) should be meticulously are donned in the appropriate PPE. Ensure that Due to the rapid spread of COVID-19, the abil- performed according to standard guidelines, a plan for an unanticipated difficult airway has ity of health care organizations to prepare for specifically after removing gloves; after contact been discussed and the desired rescue equip- increasing admissions and implement risk miti- with soiled or contaminated areas; before ment is immediately available, including a gation strategies has been time-pressured. Anxi- touching the anesthesia machine, the anesthe- supraglottic airway and a surgical airway kit. ety and fear placed additional pressure on sia cart or its contents; and after every contact providers, in particular due to concerns of inade- Prepare intubating equipment in close prox- with the patient (e.g., placement of thermome- quate supplies of personal protective equipment imity to the patient, and plan for its disposal in a ter, nasogastric tube). (PPE) and a lack of clarity of information or unified manner that limits the distance of travel of con- thinking amongst leaders. We’ve learned that Personal Protective Equipment:22,27,28 taminated equipment. Consider using the discordant messages cause confusion, create Personal protective equipment should be double gloving technique during intubation, tension, and slow protocol implementation. Fur- available for all providers and should include an sheathing the laryngoscope blade with your thermore, keeping up with rapidly changing N95 respirator (or equivalent) or a powered air- outer gloves immediately following intubation. guidelines and communicating them clearly to purifying respirator (PAPR), eye protection such See “COVID-19 Perioperative an entire organization is challenging. We recom- as goggles or a face shield, a disposable head Considerations,” Next Page APSF NEWSLETTER June 2020 PAGE 37

Recommendations for COVID-19 Patient Airway Management

From “COVID-19 Perioperative Considerations,” Previous Page Alternatively, place the used laryngoscope directly into a sealed bag and then remove your outer layer of gloves.25 Extubation often results in greater aerosol generation compared to intubation and should be performed with strict adherence to PPE, as described above. Ensure that other HCWs in the room (e.g., respiratory therapist and nurse) also wear PPE. Consider the use of gauze or a protective cloth barrier to cover the mouth and nose during extubation. Carefully dispose of contaminated equipment. Strongly consider prophylactic antiemetics to reduce the risk of vomiting and possible viral spread. Perioperative Workflow Planning and Simula- tion Training: Review the need for specific perioperative workflows for the management of COVID-19 patients within your organization.29 This may require workflow redesign, checklist imple- mentation, and testing in real time to reveal hazards or gaps in care. Designate specific Infected cases should be recovered in the 8. Preoxygenate for a minimum of 5 minutes operating room or transferred to ICU into a with 100% oxygen, or until a desired target ORs for COVID-19 patients and minimize con- negative pressure room. Have a clamp end tidal O2 is achieved. tamination by removing unneeded contents ready for circuit disconnections. and applying plastic coverings to nonmobile 9. Perform a rapid sequence induction (RSI) in equipment. We recommend team training 3. Ensure that sufficient equipment for airway order to avoid manual ventilation of patient’s lungs. Ensure a skilled assistant is available through in-situ simulation drills to promote manipulation and contingencies are avail- able. In addition, make sure that a high qual- to perform cricoid pressure. If manual venti- awareness of perioperative changes for ity HME (Heat and Moisture Exchanging) lation is required during a modified RSI, COVID-19 patients and encourage the devel- filter, rated to remove at least 99.97% of air- apply small tidal volumes, ensuring an HME opment of a shared mental model amongst borne particles 0.3 microns or greater, and filter is in place. health care teams.30 Simulation training in don- an endotracheal tube-clamp are available 10. Immediately following intubation, inflate the ning and doffing PPE, intubating, extubating, before proceeding with intubation. ETT cuff, before applying positive pressure and managing an adverse event in a COVID-19 During Airway Manipulation: ventilation. patient is also recommended. Some of the 4. Apply a fit-tested disposable N95 respirator, 11. Ensure the placement of a high quality HME authors’ institutional online resources are avail- PAPR, or an equivalent mask, eye protection, able at: https://www.anesthesiaeducation.net/ filter between the facemask/endotracheal gown, 2 sets of gloves, and protective foot- tube and breathing circuit or reservoir bag at qsi_covid19/. wear. Apply standard monitoring to the all times. patient, as you would for any induction of RECOMMENDATIONS FOR AIRWAY anesthesia. 12. Resheath the laryngoscope immediately MANAGEMENT IN A PATIENT post intubation or place within a sealed WITH SUSPECTED OR CONFIRMED 5. Designate the most experienced anesthesia specimen bag. Seal all used airway CORONAVIRUS (SARS COV-2) professional available to perform intubation, equipment in a double zip-locked plastic INFECTION if possible. Avoid trainee intubations of sus- bag. The used airway equipment must pected or confirmed SARS CoV-2 infected General Precautions: then be removed for decontamination and cases during this time. disinfection. 1. Your personal protection is the priority. Per- sonal protective equipment (PPE) should be 6. Discuss the plan for an unanticipated difficult 13. Extubation should occur under strict adher- available to all providers to ensure airborne/ airway and ensure that desired rescue ence to PPE. Consider the use of a protec- droplet/contact isolation precautions can be equipment is immediately available, includ- tive cloth barrier to cover the mouth and achieved. Review protocols for donning and ing a supraglottic airway and a surgical nose during extubation. Carefully dispose of doffing PPE. Plan ahead in order to allow airway kit. contaminated equipment. sufficient time for staff to apply PPE and -bar 7. Avoid awake fiberoptic intubations unless 14. After removing protective equipment, rier precautions. Careful attention is specifically indicated. Atomized local anes- remember to avoid touching your hair or required to avoid self-contamination. thetic will aerosolize the virus, so alternate face before washing hands. 2. Confirmed or suspected SARS CoV-2 infected topicalization techniques should be used if this procedure is indicated. Use equipment 15. Consider tracking symptoms in health care cases should NOT be brought to holding or workers involved in airway manipulation of a PACU areas. A designated OR should be most familiar to the intubator; a video-laryngo- allocated for such cases and signs posted scope is recommended as the primary intu- See “COVID-19 Perioperative 31 on the doors to minimize staff exposure. bating device to improve intubation success. Considerations,” Next Page APSF NEWSLETTER June 2020 PAGE 38

Recommendations for Resuming Elective Perioperative Services

From “COVID-19 Perioperative Considerations,” Previous Page COVID-19 patient, at a local level or using an online platform such as the https://intubate- covid.org registry. Recommendations for Resuming Nonurgent or Elective Perioperative Services As health systems begin planning to resume nonurgent operative cases, and subsequently, elective cases with ongoing flattening of the SARS-Cov2 infection curve, it remains critical to continue to adhere to the highest evidence- based standards, from local, national, and inter- national guidelines, in order to protect patients and HCWs. Resurgence of COVID-19 remains a Recommendations for Preoperative Testing a. CDC-recommended test-based strategy strong possibility and concern for a multitude of Preoperative testing is being implemented i. Resolution of fever without the use of reasons, including variations in testing availabil- across the world with three main goals. They are fever-reducing medications ity, lack of clarity on immunity conferred by prior • Delay elective surgery in patients who are ii. Improvement in respiratory symptoms 32 exposure, prevalence of disease, etc. There- either symptomatic or test positive. iii. Negative results from two SARS-CoV-2 fore, the need for ongoing surveillance, with tests ≥ 24 hours apart emphasis on continuous public efforts, should • Trigger perioperative protocols for the appro- be encouraged. priate care of suspected or confirmed b. CDC non-test-based strategy COVID-19. i. At least 72 hours since resolution of In anticipation of reopening nonurgent/elec- • Guide appropriate use of PPE and periopera- fever, without the use of fever-reducing tive perioperative services, we recommend care- tive care protocols. medications, and improvement in respi- ful institutional planning with a slow, phased ratory symptoms resumption of nonurgent cases, as suggested in We support the recommendations issued in ii. At least 7 days since symptoms first the Joint Statement from the American College a joint statement by the ASA and APSF (ASA appeared. of Surgeons (ACS), American Society of Anes- and APSF Joint Statement on Perioperative 37 4. Recommendations regarding the definition thesiologists (ASA), American Hospital Associa- Testing for the COVID-19 Virus). A population of sufficient recovery from the physiologic tion (AHA), and Association of Perioperative risk assessment identifying the prevalence of changes from SARS-CoV-2 cannot be made Registered Nurses (AORN) (Roadmap for Resum- SARS-CoV-2 should be reviewed. at this time; however, evaluation should 33 ing Elective Surgery after COVID-19 Pandemic). When There is Local or Regional Presence of include an assessment of the patient’s exer- 38 Institutional policies and workflows for resuming SARS-CoV-2: cise capacity (metabolic equivalents or METS). nonurgent/elective cases should take into con- 1. All patients should be screened for symptoms When There is Little or No Regional Presence sideration testing availability, local disease preva- prior to presenting to the hospital. Patients of SARS-CoV-2: lence, surgical procedure and indication, hospital reporting symptoms should be referred for 1. All patients should be screened for symp- and ICU capacity, and staffing requirements. additional evaluation. All other patients toms before presenting to the hospital. Physical workspaces should be mapped out to should undergo nucleic acid amplification optimize patient and provider distancing. Provi- testing (including PCR tests) prior to undergo- 2. Patients reporting symptoms should be sions should continue to be made for ongoing ing non-emergent surgery. Health care sys- referred for further evaluation. staff training and support for the overall hospital tems may consider encouraging patients to COMMENT response to COVID-19.34 In accordance with the self-isolate pending testing results. Without any current vaccinations or proven joint statement above, we advocate for a phased 2. Because false negatives may occur with test- pharmacological interventions, we recommend approach to resuming medically indicated, time- ing, droplet precautions (surgical mask and continuous emphasis on public health efforts 34–36 sensitive surgeries. We favor policies and eye covering) should be used by OR staff for and nonpharmacological interventions protocols that prioritize patients’ clinical needs operative cases. Before performing an aero- endorsed by the Center for Disease Control and organizational capacity as a way to mitigate sol-generating procedure, health care provid- (CDC), World Health Organization (WHO), and the competition for limited operating capacity. ers within the room should wear an N95 local state governments. We also advocate for The cornerstone of risk management during mask, eye protection, gloves, and a gown. the continuous leveraging of technology (tele- medicine) in the perioperative setting to facili- pandemic recovery will remain symptom-based 3. If a patient tests positive for SARS-CoV-2, elec- tate adequate social distancing and mitigate preoperative screening. Most hospitals have a tive surgical procedures should be delayed nosocomial transmissions.39 dedicated service to ensure that symptom-posi- until the patient is no longer infectious and has tive patients have a clear pathway for delaying demonstrated recovery from COVID-19. A See “COVID-19 Perioperative surgery and follow-up in 14 days where possible. patient may be infectious until either: Considerations,” Next Page APSF NEWSLETTER June 2020 PAGE 39

COVID-19 Perioperative Considerations References (Cont)

From “COVID-19 Perioperative Considerations,” 11. Kamming D, Gardam M, Chung F. Editorial I. Anaesthesia and 27. Seto WH, Tsang D, Yung RWH, et al. Effectiveness of precau- Previous Page SARS. Br J Anaesth. 2003;90:715–718. tions against droplets and contact in prevention of nosocomial

Dr. Liana Zucco is a perioperative quality & safety 12. Li H, Liu S-M, Yu X-H, et al. Coronavirus disease 2019 (COVID- transmission of severe acute respiratory syndrome (SARS). 19): current status and future perspective. Int J Antimicrob Lancet. 2003;361:1519–1520. fellow in Anesthesiology at the Beth Israel Dea- Agents. 2020;2019(xxxx):105951. doi:10.1016/j.ijantimi- 28. ASA, APSF, AAAA, AANA. The use of personal protective coness Medical Centre and a Master’s in Health- cag.2020.105951 equipment by anesthesia professionals during the COVID-19 care Quality & Safety candidate at Harvard 13. Centers for Disease Control and Prevention. Cleaning and dis- pandemic. Anesthesia Patient Safety Foundation. https://www. infection for households. Coronavirus Disease 2019 (COVID- apsf.org/news-updates/the-use-of-personal-protective-equip- Medical School, Boston, MA. 19). https://www.cdc.gov/coronavirus/2019-ncov/ ment-by-anesthesia-professionals-during-the-covid-19-pan- demic/. Accessed on April, 20, 2020. Dr. Nadav Levy is a perioperative quality & safety prevent-getting-sick/cleaning-disinfection.html. Accessed May 8, 2020. 29. Wax RS, Christian MD. Practical recommendations for critical fellow in Anesthesiology at the Beth Israel Dea- 14. Rothan HA, Byrareddy SN. The epidemiology and pathogene- care and anesthesiology teams caring for novel coronavirus coness Medical Centre and a Master’s in Health- sis of coronavirus disease (COVID-19) outbreak. J Autoimmun. (2019-nCoV) patients. Can J Anesth. 2020. doi:10.1007/s12630- care Quality & Safety candidate at Harvard 2020;109(February):102433. doi:10.1016/j.jaut.2020.102433 020-01591-x 15. van Doremalen N, Bushmaker T, Morris D, et al. Aerosol and 30. Dieckmann P, Torgeirsen K, Qvindesland SA, et al. The use of Medical School, Boston, MA. surface stability of SARS-CoV-2 as compared with SARS-CoV-1. simulation to prepare and improve responses to infectious dis- Dr. Desire Ketchandji is a critical care medicine N Engl J Med. 2010;382:1564-1567: ease outbreaks like COVID-19: practical tips and resources 16. Chen YC, Huang LM, Chan CC, et al. SARS in hospital emer- from Norway, Denmark, and the UK. Adv Simul (London, Eng- fellow in Anesthesiology at Oregon Health and gency room. Emerg Infect Dis. 2004;10:782–788. land). 2020;5:3. Science University, Portland, OR. 17. Booth CM, Matukas LM, Tomlinson GA, et al. Clinical features 31. Cook TM, El-Boghdadly K, McGuire B, et al. Consensus guide- and short-term outcomes of 144 patients with SARS in the lines for managing the airway in patients with COVID-19. Dr. Michael Aziz is the interim vice chair of Clinical greater Toronto area. J Am Med Assoc. 2003;289: Anaesthesia. 2020:1–15. Affairs and professor in the Department of Anes- 2801–2809. 32. Kissler SM, Tedijanto C, Goldstein E, et al. Projecting the trans- thesiology and Perioperative Medicine at Oregon 18. Caputo KM, Byrick R, Chapman MG, et al. Intubation of SARS mission dynamics of SARS-CoV-2 through the postpandemic patients: infection and perspectives of healthcare workers. Can period. Science (80- ). April 2020:eabb5793. doi:10.1126/sci- Health and Science University, Portland, OR. J Anesth. 2006;53:122–129. ence.abb5793 Dr. Satya Krishna Ramachandran is the vice chair 19. Iwashyna TJ, Boehman A, Capelcelatro J, et al. Variation in 33. ACS, ASA, AORN, AHA. Joint statement: roadmap for resuming aerosol production across oxygen delivery devices in sponta- elective surgery after COVID-19 pandemic. https://www.asahq. of Quality, Safety and Innovation, associate pro- neously breathing human subjects. medRxiv. org/about-asa/newsroom/news-releases/2020/04/joint-state- fessor of Anesthesia, Department of Anesthesia, 2020:2020.04.15.20066688. doi:10.1101/2020.04.15. ment-on-elective-surgery-after-covid-19-pandemic. Published Critical Care and Pain Medicine, Beth Israel Dea- 20066688 2020. Accessed April 25, 2020. 20. He X, Lau EH, Wu P, et al. Temporal dynamics in viral shedding 34. COVIDSurg Collaborative. Global guidance for surgical care coness Medical Center, Harvard Medical School, and transmissibility of COVID-19. medRxiv. during the COVID-19 pandemic. Br J Surg. 2020;(March). Boston, MA. 2020:2020.03.15.20036707. doi:10.1101/2020.03.15. doi:10.1002/bjs.11646 20036707 35. Prachand VN, Milner R, Angelos P, et al. Medically necessary, Drs. Zucco, Levy, Ketchandji and Aziz have no 21. Spicer K, Bardossy AC, Oakley LP, et al. Presymptomatic SARS- time-sensitive procedures: scoring system to ethically and effi- conflicts of interest. Dr. Ramachandran receives CoV-2 infections and transmission in a skilled nursing facility. ciently manage resource scarcity and provider risk during the personal fees from Fresenius Kabi USA (scientific NEJM: April 24, 2020:1–10. DOI: 10.1056/NEJMoa2008457 COVID-19 pandemic. J Am Coll Surg. 2020. doi:10.1016/j.jam- advisor). 22. Ferioli M, Cisternino C, Leo V, et al. Protecting healthcare work- collsurg.2020.04.011 ers from SARS-CoV-2 infection: practical indications. Eur Respir 36. Dexter F, Parra MC, Brown JR, et al. Perioperative COVID-19 REFERENCES Rev. 2020;29:200068. defense. Anesth Analg. 2020;XXX(Xxx):1. doi:10.1213/ 23. Rowlands J, Yeager MP, Beach M, et al. Video observation to ane.0000000000004829 1. World Health Organization (WHO). Coronavirus disease situa- map hand contact and bacterial transmission in operating 37. ASA, APSF. Joint statement on non-urgent care during the tion reports. 2020. https://www.who.int/emergencies/diseases/ rooms. Am J Infect Control. 2014;42:698–701. COVID-19 outbreak. https://www.asahq.org/about-asa/news- novel-coronavirus-2019/situation-reports/. Accessed April 29, room/news-releases/2020/03/asa-apsf-joint-statement-on- 2020. 24. Loftus RW, Koff MD, Birnbach DJ. The dynamics and implica- tions of bacterial transmission events arising from the anesthe- non-urgent-care-during-the-covid-19-outbreak. Published 2. John Hopkins University. COVID-19 Dashboard by the Centre sia work area. Anesth Analg. 2015;120:853–860. 2020. Accessed April 29, 2020. for Systems Science and Engineering. Coronavirus Resource 38. Centers for Disease Control and Prevention. Overview of influ- Center. https://coronavirus.jhu.edu/map.html. Published 2020. 25. Munoz-Price LS, Bowdle A, Johnston BL, et al. Infection preven- enza surveillance in the United States. CDC webpage. 2010:1- Accessed April 29, 2020. tion in the operating room anesthesia work area. Infect Control Hosp Epidemiol. 2019;40:1–17. 5. http://www.cdc.gov/flu/weekly/pdf/overview.pdf. 3. Richardson S, Hirsch JS, Narasimhan M, et al. Presenting char- 26. Birnbach DJ, Rosen LF, Fitzpatrick M, et al. A new approach to 39. Ohannessian R, Duong TA, Odone A. Global telemedicine acteristics, comorbidities, and outcomes among 5700 patients pathogen containment in the operating room: sheathing the implementation and integration within health systems to fight hospitalized with COVID-19 in the New York City area. JAMA. laryngoscope after intubation. Anesth Analg. 2015;121:1209– the COVID-19 pandemic: a call to action. JMIR Public Heal Sur- 2020;10022:1–8. 1214. veill. 2020;6:e18810. doi:10.2196/18810 4. Arentz M, Yim E, Klaff L, et al. Characteristics and outcomes of 21 critically ill patients with COVID-19 in Washington State. JAMA. 2020;4720:2019–2021. 5. Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospi- talized patients with 2019 novel coronavirus-infected pneumo- nia in Wuhan, China. JAMA. 2020;323:1061–1069. 6. Sanche S, Lin Y, Xu C, et al. High contagiousness and rapid spread of severe acute respiratory syndrome coronavirus 2. Emerg Infect Dis. 2020. https://doi.org/10.1101/2020.02. 07.20021154 PLEASE NOTE! 7. Holshue ML, DeBolt C, Lindquist S, et al. First case of 2019 novel coronavirus in the United States. N Engl J Med. 2020;382:929–936. We have a new mailing address: 8. Fuk-Woo Chan J, Yuan S, Kok K-H, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicat- ing person-to-person transmission: a study of a family cluster. Lancet. 2020;6736:1–10. Anesthesia Patient Safety Foundation 9. Huang C, Wang Y, Li X, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan , China. Lancet. P.O. Box 6668 2020;6736:1–10. 10. Phan LT, Nguyen TV, Luong QC, et al. Importation and human- Rochester, MN 55903, U.S.A. to-human transmission of a novel coronavirus in Vietnam. N Engl J Med. 2020;(Panel D). doi:10.1056/NEJMc2001272 APSF NEWSLETTER June 2020 PAGE 40

Decontamination Strategies for Masks From “Mask Decontamination,” Cover Page before and after the decontamination treat- of most household fabric materials (data not The ultraviolet germicidal irradiation (UVGI) ment. Although COVID-19 virus is ~0.1 µm in shown) that could also be used for home-made 6 method4 was implemented with two UV systems size, the exhalation droplets can be several masks. Our data indicate there is no systematic (Clorox Optimum-UV Enlight® System, 216 mJ/ micrometers or larger but shrink while traveling change of efficiency or resistance on N95s cm2) located 1 meter (3.3 feet) away from the front in air due to water evaporation. Efficiency of caused by the treatment. The slight increase in and back of the respirators/masks hanging in the filter media is a strong function of contaminant resistance of treated N95s is from sample middle of a small decontamination room. It gener- size. We report here fractional efficiency for dif- variation, rather than the treatment itself. ated UV-C light and irradiated the masks for 5 ferent sizes from 0.03 to 0.4 µm, which repre- The test method is destructive, so we limited minutes. For the oven heating method, 77°C sents the most penetrating particle size range, our sample counts to save precious N95s (170°F) was chosen because it is the lowest tem- so that it can be compared to the size of COVID- and masks. 19 virus or other pathogens of interest. As perature setting for most household ovens, and The quantitative fit tests were performed using shown in Figure 1, N95 respirator has >95% effi- COVID-19 virus is deactivated at 70°C.5 At the a TSI PortaCount® Pro+ 8038 by a specific ciency over the entire size range, with the least target temperature, the respirators/masks were researcher in this study. The fit factor, defined as efficiency of 96% at 0.05-0.08 µm, and is >98% placed on a stack of coffee filters inside the the ratio of ambient particle concentration to the efficient at COVID-19 virus size of 0.1 µm. Surgi- oven without touching any metal surfaces to ~ particle concentration inside the respirator, should cal mask and procedure mask have lower effi- prevent thermal damage and heated for 30 be equal to or above 100 to pass the test. The ciency with 85% and 80% at 0.1 µm, minutes. For the steam heat treatment method, ~ ~ respectively. All three decontamination treat- quantitative fit testing was first performed with a the respirators/masks were placed on the rack ments did not cause visible deformation or new 3M 8210 N95 respirator and then performed of a steamer with boiling water for 30 minutes. degradation of the material nor did they after 1, 3, 5, and 10 cycles of 77°C oven treatment This treatment should not be done in a micro- degrade filtration efficiency or breathability with the same respirator. A second 3M 8210 N95 wave oven because the metal nose clip may after as many as 10 treatments. The only excep- respirator was fit tested after 1, 3, 5, and 10 cycles damage both the respirators/masks and the tion is that the steam heat treatment caused a of steam heat treatment. As shown in Table 1, microwave oven. slight efficiency drop (<5% on the average) in oven treatment was deemed safe for the integrity Filtration efficiency and breathing resistance surgical masks after 10 treatment cycles, sug- and the fit of the respirator, while the steam heat of 3M 8210 N95 respirator (St. Paul, MN.), 3M gesting that oven heating is a better option for treatment may affect the respirator fit. All the fit 1820 procedure mask, and Halyard 48207 sur- repetitive reuse. The three decontamination tests were performed with the same person. gical mask (Alpharetta, GA) were measured methods were tested safe in retaining filtration See “Mask Decontamination,” Next Page

100% Treatments Treatments New (Untreated)

N95 New (Untreated) 95% Oven Oven 77 °C 3077°C min 30 - min–1010 treatments treatments Steam Steam Heat 3030 min min–10 - 10 treatments treatments UVGI 5 min UVG 5 min 90% SolidSolid Line: line: N95–3M 8210 Dashed Line: N95 Surgical- 3M 8210 Mask–Halyard 48207 Dashed line: 85% Dotted Line: Surgical Procedure Mask Mask–3M - Halyard 1820 48207 Dotted line: Procedure Mask - 3M 1820

80% Surgical Mask Breathing Resistance 100 New (Untreated) Oven 77 °C 30 min - 10 treatments 75% Steam Heat 30 min - 10 treatments 80 UVGI 5 min Particle Filtration Efficiency 70% 60

40

65% Procedure Mask 20 Differential Pressure @ 10.5 cm/s (Pa) Differential

0 60% N95 Surgical Mask Procedure Mask 0.02 0.05 0.1 0.2 0.5 Particle Mobility Diameter (μm) Figure 1: Fractional Particle Filtration Efficiency and Breathing Resistance (Differential Pressure) of the decontamination treated samples of 3M 8210 N95, Halyard 48207 surgical mask, and 3M 1820 procedure mask, compared with the new untreated samples. APSF NEWSLETTER June 2020 PAGE 41

Decontamination of Respirators and Masks From “Mask Decontamination,” Previous Page Table 1. Quantitative Fit Testing Results of the New N95 Respirator and After Oven Different fit factors should be expected if the and Steam Heat Treatment Cycles tests were performed on a different wearer, even with the same respirator. During the fit Oven Treatment testing, the person who conducted the tests did Exercise New Cycles not feel any difference in terms of breathability between untreated and treated N95s. 1 3 5 10 Normal Breathing 200+ 200+ 200+ 200+ 200+ CONCLUSION: We tested three methods (UVGI, Oven, and Deep Breathing 200+ 200+ 200+ 200+ 200+ Steam Heat) for decontamination and found Head Side to Side 200+ 200+ 200+ 200+ 200+ that they did not degrade the filtration effi- Head Up and Down 200+ 200+ 200+ 200+ 200+ ciency and fit factor. Based on our present find- ings, the reuse respirators and masks are not Talking 135 134 124 170 125 only highly efficient but can be used repeatedly Grimace Excl. Excl. Excl. Excl. Excl. for up to 10 times. Moreover, the methods are Bending Over 200+ 200+ 151 197 200+ readily available not only in the hospital setting but also in most home environments. This study Normal Breathing 200+ 200+ 200+ 200+ 200+ only tested unused respirator/mask perfor- Overall Fit Factor 188 188 177 195 185 mance after multiple decontamination treat- ments. Worn respirator/mask may have deterioration in integrity and efficiency, which Steam Heat Treatment cannot be recovered from decontamination. Exercise New Cycles We do not recommend reusing N95s or masks 1 3 5 10 that are visibly contaminated or have visible deterioration on any part of the materials. Normal Breathing 200+ 200+ 191 109 141 Collaborators (all at the University of Minnesota): Deep Breathing 200+ 200+ 200+ 184 179 Qisheng Ou, PhD, research associate, Head Side to Side 200+ 200+ 92 43 51 Mechanical Engineering Department Head Up and Down 200+ 165 101 72 99 Chenxing Pei, PhD, student, Mechanical Talking 135 86 80 56 58 Engineering Department Seong Chan Kim, PhD, senior research scientist, Grimace Excl. Excl. Excl. Excl. Excl. Mechanical Engineering Department Bending Over 200+ 144 136 47 37 Linsey Griffin, PhD, assistant professor of Normal Breathing 200+ 157 180 112 50 Apparel Design, College of Design Overall Fit Factor 188 152 124 70 66 William Durfee, PhD, professor, Mechanical Engineering Department The numbers in the table represent the Fit Factor. A fit factor above 100 represents an appropriate fit John Bischof, PhD, professor, Mechanical (and is represented in green). A fit factor below 100 represents a poor fit (and is represented in red). Engineering Department Rumi Faizer, MD, associate professor, REFERENCES 4. Mills D, Harnish DA, Lawrence C, et al. Ultraviolet germicidal Department of Surgery 1. Livingston E, Desai A, Berkwits M. Sourcing personal pro- irradiation of influenza-contaminated N95 filtering face- tective equipment during the COVID-19 pandemic. JAMA. piece respirators. American Journal of Infection Control. Kumar Belani, MBBS, MS, professor of Published online March 28, 2020. https://jamanetwork. 2018;46:e49–e55. Anesthesiology com/journals/jama/fullarticle/2764031 5. Chin AWH, Chu JTS, Perera MRA, et al. Stability of SARS- David Y. H. Pui, PhD, Regents Professor, 2. Decontamination and reuse of filtering facepiece respira- CoV-2 in different environmental conditions. The Lancet tors. https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe- Microbe. Published online April 2, 2020. doi:10.1016/S2666- Mechanical Engineering Department strategy/decontamination-reuse-respirators.html. 5247(20)30003-3 The authors have no conflicts of interest. Dr. Qisheng 3. Coronavirus (COVID-19) Update: reusing face masks and N95 respirators: JAMA. Published online April 8, 2020. 6. Zhu N, Zhang D, Wang W, et al. A Novel Coronavirus from Ou, Mr. Chenxing Pei, Dr. Seong Chan Kim, and Dr. patients with pneumonia in China, 2019. New England Jour- David Y.H. Pui contributed equally to this letter. URL: https://edhub.ama-assn.org/jn-learning/audio- player/18433414 nal of Medicine. 2020;382:727–733.

YOUR SUPPORT IS MORE IMPORTANT THAN EVER! Please donate online at apsf.org, or make checks payable to the APSF and mail donations to: Anesthesia Patient Safety Foundation (APSF), P.O. Box 6668, Rochester, MN 55903, U.S.A. APSF NEWSLETTER June 2020 PAGE 42

Postoperative Recurarization After Sugammadex Administration Due to the Lack of Appropriate Neuromuscular Monitoring: The Japanese Experience by Tomoki Sasakawa, MD, PhD; Katsuyuki Miyasaka, MD, PhD; Tomohiro Sawa, MD, PhD; and Hiroki Iida, MD, PhD INTRODUCTION muscle relaxation monitoring is a method for Sugammadex rapidly reverses neuromuscu- evaluating the degree of muscle relaxation lar blockade via selective encapsulation of objectively using accelerometer, electromyo- rocuronium and other nondepolarizing grams, etc., in conjunction with electric nerve aminosteroid muscle relaxants. Since its 2010 stimulation. Quantitative monitoring enables launch in Japan, sugammadex has been admin- evaluation of whether the TOF ratio, which is an istered to an estimated 12.32 million patients index of recovery from muscle relaxation, is over 8 years. Sugammadex has contributed to greater than 0.9. Evaluation of a deeper degree safe and effective management of muscle func- of muscle relaxation, using the Post-Tetanic tion by reducing the risk of postoperative resid- Count (PTC) is also possible. Qualitative monitor- ual neuromuscular blockade (sugammadex ing is based on an anesthesia professional’s sub- 1–4% vs neostigmine 25–60%).1 However, the jective judgment with palpating or observing Safety Committee of the Japanese Society of muscle contractions using a device with only a Anesthesiologists (JSA) released a warning in nerve stimulation function. While it may be pos- 2019 highlighting the need for correct sugam- sible to obtain an approximate TOF count, it is By Fvasconcellos (Own work) [Public domain], via Wikimedia Commons madex dosing.2 This warning was based on 36 not possible to obtain the precision crucial for Space-filling model of sugammadex sodium. cases of recurrence of neuromuscular block- distinguishing exact TOF ratios, for example, ade (recurarization) reported by the end of 2018 between 0.8 and 0.93. in Japan. The appropriate dose of sugamma- muscular junction has a large safety factor However, a survey showed that quantitative dex should be determined based on the under various physiological conditions. In the monitors were available to only 22.7% of anes- patient’s body weight and depth of neuromus- case mentioned above, muscle strength was thesia practitioners in the United States.4 In addi- cular blockade (Table 1). Moreover, the anesthe- apparently normal. However, in the presence of tion, the use of qualitative or quantitative sia professional should check for signs of low concentrations of muscle relaxants, recura- monitors is not common in Japan. In most cases, anaphylactic reactions and recurarization after rization may occur with the onset of respiratory anesthesia professionals subjectively judge sugammadex injection while monitoring for full acidosis, administration of or ami- recovery of muscle relaxation based on clinical neuromuscular recovery. noglycoside antibiotics, or other factors that signs. Since the availability of neuromuscular decrease the safety factor. Some rocuronium Many incidents reported in Japan involved monitors is likely to be similar in Japan and the molecules remain unbound in the central com- inappropriate dose determination (lack of neuro- United States, the lack of appropriate periopera- partment in some patients who receive an muscular monitoring) and insufficient postdose tive monitoring may be a major cause of inap- insufficient dose of sugammadex. These free management. Perioperative neuromuscular propriate dosing of neuromuscular blockade. monitoring with a quantitative device, which molecules may redistribute to the peripheral measures and displays a train-of-four (TOF) ratio, RECURARIZATION compartment, migrate to the neuromuscular is the gold standard for avoiding postoperative Recurarization, or a rapid increase in neuro- junction, and cause further muscle relaxation. residual neuromuscular blockade.3 Quantitative muscular blockade after a period of recovery, TWO CASES OF RECURARIZATION was reported in the past with the use of acetyl- Case No. 1. A 70-year-old, 71-kg male patient cholinesterase inhibitors, but is increasingly underwent ureterectomy. The patient had Table 1. Recommended Doses of being reported with sugammadex, where chronic renal insufficiency. In total, 240 mg of Sugammadex for Reversal of muscle strength appears to recover more reli- rocuronium was administered during anesthesia, Neuromuscular Blockade Based on ably. Elveld et al. reported recurrence of neuro- Neuromuscular Monitoring12 which lasted for 7 hours and 33 minutes. Sugam- muscular blockade during reversal with a small madex 200 mg was administered 87 minutes Level of Neuromuscular Sugammadex dose of sugammadex at a PTC of 1 (i.e., deep after the last 20-mg dose of rocuronium. The Blockade Dose12 (mg/kg) 5 muscle relaxation). In a subsequent clinical case patient resumed spontaneous respiration. The Moderate 2 report, an obese patient experienced recurariza- patient was responsive to verbal communication (Reappearance of T2 in tion due to an insufficient dose of sugammadex and extubated. No neuromuscular monitoring response to TOF that necessitated tracheal re-intubation after a stimulation) was performed. Fifteen minutes after the patient TOF ratio of 0.9 was observed prior to extuba- was moved to the post-anesthesia care unit Deep 4 tion for the first time.6 (At reappearance of 1 or 2 (PACU), he stopped breathing and reintubation PTCs) MECHANISM OF RECURARIZATION was performed. The neuromuscular monitor dis- played a TOF count of 3. Upon administration of Immediate reversal of 16 Even when muscle relaxant molecules another 200-mg dose of sugammadex, body neuromuscular blockade occupy 75% of the nicotinic (3 minutes after an movements reappeared, spontaneous respira- receptors at the neuromuscular junction, intubating dose of tions resumed, and no signs of recurarization ) normal neuromuscular transmission is achieved were observed thereafter. T2, second twitch. TOF, train-of-four. PTC, post- because the remaining 25% of receptors allow tetanic count. for normal muscle strength.7 Thus, the neuro- See “Recurarization,” Next Page APSF NEWSLETTER June 2020 PAGE 43

Neuromuscular Monitoring Should be Coupled with Use of Sugammadex

From “Recurarization,” Preceding Page formed where appropriate.” Although no spe- muscular monitoring data. Moreover, we call for Case No. 2. An 80-year-old, 61-kg male cific monitoring methods were mentioned in clinical attention to prevent recurarization, ana- patient underwent surgical abdominal aortic the latest edition, the use of a quantitative neu- phylactic reactions, and other postoperative aneurysm repair. Rocuronium (50 mg) was romuscular monitor is desirable in all cases. complications associated with the use of muscle administered for endotracheal intubation and Qualitative and semi-qualitative neuromuscular relaxants and their antagonists. monitoring methods, such as clinical muscle 25-mg doses were injected at 30-minute inter- Dr. Sasakawa is an associate professor in the vals starting at 1 hour after intubation. No neu- function tests (e.g., 5-second head lift and sus- Department of Anesthesiology and Critical Care romuscular monitoring was performed. Fifty tained hand grip), can only detect TOF ratios of Medicine at Asahikawa Medical University, Asa- minutes after the last 25-mg dose of 0.4 or less and do not correlate with a TOF ratio hikawa, Hokkaido, Japan. rocuronium was administered, 200 mg of of 0.9, a threshold indicating the absence of 10 sugammadex was injected in the absence of residual paralysis. Perioperative evaluation Dr. Miyasaka is a professor in the Department of consciousness and spontaneous respirations. and management of deep muscle relaxation Perianesthesia Nursing at St. Luke’s Interna- Following the administration of sugammadex, during anesthesia requires neuromuscular tional University, Tokyo, Japan. weak spontaneous breathing was noted. The monitoring based on PTC or other reliable 3 Dr. Sawa is a professor in the Department of patient was responsive to verbal communica- parameters. Anesthesia at Teikyo University, Teikyo, Japan. tion, extubated, and transferred to the PACU. Fifteen minutes after extubation, breathing INCREASING THE USE OF Dr. Iida is a professor and chair of the Depart- NEUROMUSCULAR MONITORING stopped. Spontaneous respiration was restored ment of Anesthesiology and Pain Medicine at Japan’s national medical insurance system immediately after an additional 200-mg dose of the Gifu University Graduate School of Medi- does not promote the use of neuromuscular sugammadex was injected. cine, Gifu, Japan. monitoring in clinical settings because it does NEUROMUSCULAR MONITORING AND not reimburse for the medical expenses The authors have no conflicts of interest. All authors are CORRECT USE OF SUGAMMADEX incurred by neuromuscular monitoring. In addi- members of the Safety Committee of the Japanese Neuromuscular monitoring was not per- tion, the sale of the stand-alone portable accel- Society of Anesthesiologists. formed intraoperatively or before administra- eromyography (AMG)-based devices has been tion of sugammadex in either case. These discontinued. This has significantly narrowed REFERENCES the range of options, discouraging the pur- 1. Kotake Y, Ochiai R, Suzuki T, et al. Reversal with sugamma- cases show the occurrence of recurarization in dex in the absence of monitoring did not preclude residual elderly patients with presumably high chase of new monitors. However, several new neuromuscular block. Anesth Analg. 2013;117:345–51. rocuronium sensitivity due to pharmacokinetic quantitative neuromuscular monitors have 2. Japanese Society of Anestheiologists. Medical alert: appro- and pharmacodynamic factors. Recently, there been launched in the market and are attracting priate use of sugammadex (in Japanese) 2019. is a trend to administer relatively large doses of the interest of anesthesia professionals. New https://anesth.or.jp/users/news/detail/5c6e37f8-2d98- 4ec8-b342-197fa50cc6ad device types include electromyography-based rocuronium to maintain deep relaxation 3. Murphy GS. Neuromuscular monitoring in the perioperative because deep neuromuscular blockade may monitors, AMG-based monitors that employ period. Anesth Analg. 2018;126:464–8. result in improved operative conditions for lapa- new measurement algorithms (3-dimensional 4. Naguib M, Kopman AF, Lien CA, et al. A survey of current roscopic surgery compared with moderate accelerometer), and monitors that comprise a management of neuromuscular block in the United States blockade.8 Given the risk of rocuronium over- modified blood pressure cuff with neuromuscu- and Europe. Anesth Analg. 2010; 111:110–9. dosing, deep neuromuscular blockade should lar electrodes on the inside.11 The advantages of 5. Eleveld DJ, Kuizenga K, Proost JH, et al. A temporary decrease in twitch response during reversal of rocuronium- be assessed using intraoperative neuromuscu- these new models include ease of calibration, induced muscle relaxation with a small dose of sugamma- lar monitoring. If rocuronium overdose results in ease of use, and presence of adaptive mecha- dex. Anesth Analg. 2007; 04:582–4. profound muscle relaxation and disappearance nisms to compensate for postural changes. 6. Le Corre F, Nejmeddine S, Fatahine C, et al. Recurarization of the twitch response, it is important to wait for However, given their short post-launch duration after sugammadex reversal in an obese patient. Can J Anaesth. 2011;58:944–7. spontaneous recovery (initially assessed based and high cost, the medical community is waiting 7. Waud DR, Waud BE. In vitro measurement of margin of on PTC). In the two cases described earlier, one for quality products with time-tested reputations safety of neuromuscular transmission. Am J Physiol. 1975; vial of sugammadex (200 mg) was adminis- and competitive prices. 229:1632–4. tered on a routine basis in the absence of neu- 8. Martini CH, Boon M, Bevers RF, et al. Evaluation of surgical romuscular monitoring, which led to under CONCLUSIONS conditions during laparoscopic surgery in patients with The frequent absence of perioperative neuro- moderate vs deep neuromuscular block. Br J Anaesth. dosing and eventual recurarization. 2014;112:498–505. muscular monitoring has increased the risk of 9. Japanese Society of Anestheiologists. Standards and REVISED JSA GUIDELINES FOR recurarization due to inappropriate sugamma- guidelines: monitoring during anesthesia (in Japanese) MONITORING DURING ANESTHESIA dex dosing in Japan. In light of the increasing use 2019. https://anesth.or.jp/files/pdf/monitor3_20190509.pdf As compared with earlier editions, the 2019 of sugammadex worldwide, we acknowledge 10. Plaud B, Debaene B, Donati F, Marty J. Residual paralysis revision of the JSA Guidelines for Monitoring the need to warn the medical community that after emergence from anesthesia. Anesthesiology. 2010; 112:1013–22. During Anesthesia included a more definitive the risk of recurarization is high in many parts of 11. Markle A, Graf N, Horn K, et al. Neuromuscular monitoring recommendation on the use of neuromuscular the world. In conclusion, we invite medical using TOF-Cuff® versus TOF-Scan®: an observational study monitoring: “Neuromuscular monitoring should device manufacturers to produce price-compet- under clinical anesthesia conditions. Minerva Anestesiol. be performed in patients receiving muscle itive and easy-to-operate neuromuscular moni- 2020 Feb 17 [Online ahead of print] DOI:10.23736/ S0375-9393.20.14272–X. relaxants and their antagonists.”9 This recom- tors that can be used throughout perioperative 12. MERCK & Co.,Inc. Bridion (sugammadex) : Prescribing drug mendation replaced the previous version: care. We also encourage anesthesia profession- information. https://www.merck.com/product/usa/pi_ “Neuromuscular monitoring should be per- als to administer sugammadex based on neuro- circulars/b/bridion/bridion_pi.pdf Accessed May 11, 2020. APSF NEWSLETTER June 2020 PAGE 44

Effective Leadership and Patient Safety Culture by Brooke Albright-Trainer, MD; Rakhi Dayal, MD; Aalok Agarwala, MD, MBA; and Erin Pukenas, MD

Effective leadership is necessary in medicine tribute to burnout (Figure 1). Burnout is a syn- to foster an organizational climate that pro- drome conceptualized as resulting from chronic motes patient safety. Leadership is the corner- workplace stress that has not been successfully stone of success to any project or business. managed.7 Traditionally, organizational culture in Effective leaders lead by example, value a health care has not allowed room for a discus- strong work ethic, and demonstrate a commit- sion of work-life balance. Providers have feared ment to the mission of an institution or depart- voicing concerns regarding their personal needs ment beyond that of self-preservation.1 that may not align with departmental or institu- Capable leaders use a clear vision to instill a tional goals. Some institutions may only start to larger sense of purpose, setting the tone for the pay attention to burnout when it begins to con- direction of an organization. Leaders who pro- tribute to loss of productivity, patient access, mote a positive and cohesive work environ- lower patient safety scores, and increased costs. ment engender trust among providers and staff Frequent management changeover or uncer- and establish psychological safety for employ- tainty, lack of a strategic plan, or goal incongru- ees. Leadership determines organizational pri- ence can lead to physicians feeling devalued or orities and can funnel resources toward Figure 1: Work-life imbalance can contribute to ineffective. High rates of turnover can be a sign important safety initiatives. Fostering an envi- employee burnout. that ineffective leadership is contributing to high ronment that encourages others to speak up retention, enhanced reputation, improved burnout rates in departments or institutions. with concerns allows leaders to act decisively patient safety and risk-management experi- Turnover leads to increased costs, recruitment and in a timely manner to protect patients and ence, and better work environments.4 expenses, agency/locum bridging, higher rates employees. Ultimately, leaders who promote a of paid time off, and need for additional support Team members who identify unsafe condi- positive organizational climate contribute to services, to name a few. higher job satisfaction among employees, tions or who have good suggestions for safety decreased burnout, fewer medical errors, and improvements should be recognized and Today, as data continue to mount relating an overall improved culture of safety.2 rewarded. Leaders can use a number of tech- burnout among health care workers to increases niques to improve safety culture, including use in incidence of medical errors and malpractice, it SAFETY CULTURE of surveys to identify culture gaps, encouraging is in every institution’s best interest to address Improving safety culture within health care teamwork training, performing executive walk- employee stress and work to successfully rounds, and establishing unit-based quality and manage it. Following the Institute of Medicine systems is an essential component of prevent- 5 ing and reducing errors. The Joint Commission safety teams. By proactively assessing system (IOM) landmark report asserting that deaths from defines safety culture as the collection of strengths and vulnerabilities, health care teams medical errors had become the third leading “beliefs, values, attitudes, perceptions, compe- can track progress and prioritize areas to cause of death in the US behind cancer and tencies, and patterns of behavior that deter- improve safety culture. heart disease, quality improvement initiatives to 8 mine the organization’s commitment to quality reduce patient harm have spawned nationwide. PSYCHOLOGICAL SAFETY and patient safety”.3 A core measure of a strong Recent studies have suggested a two-fold safety culture is the willingness of employees, Psychological safety is defined as the belief increase in medical errors when associated with one will not be punished for making an error or whether clinical or in support roles, whether clinician burnout as compared to those not asso- speaking up. It is a core component of a safe newly hired or experienced, to feel comfortable ciated with burnout, with an overwhelming 55% culture, and intertwines with both patient safety 9 speaking up when they see something amiss. It of respondents reporting burnout symptoms. If and burnout. Psychological safety allows for is imperative that leaders support and foster an these issues go unaddressed, the health care creativity, speaking one’s mind, and lack of fear environment in which speaking up is encour- professional's well-being, or potentially even the for having new, different, or dissonant ideas.6 A aged so that care teams can learn from adverse his or her safety, can become compromised. To psychologically safe environment also permits events, close calls, and unsafe conditions. This prevent burnout and increase wellness amongst providers to discuss issues related to their own can be accomplished by encouraging a trans- providers, leaders should reflect on an organiza- work-life balance. In creating psychological parent and nonpunitive approach to reporting. tion’s climate and implement change when safety, leaders must foster an environment Moving to a “just culture” where individual needed. By implementing monitoring tools, where providers feel safe communicating blame is minimized or removed, and a focus is including workplace wellness initiatives and issues with patient care. Effective leaders main- placed on system faults that contribute to workplace response teams, leaders can foster tain open lines of communication and remain adverse events, can improve a safety culture. an organizational culture that prevents burnout. open to feedback. Though this may subject one Leaders must also adopt and champion to increased vulnerability, the ability to accept KEY ATTRIBUTES OF EFFECTIVE efforts to eradicate intimidating behaviors. feedback and react constructively allows lead- LEADERS When unprofessional behavior is tolerated ers to recognize problems earlier and deal with Acquisition of certain attributes in leadership is within an organization, it undermines patient 1 them proactively. Otherwise, team members so important that a multitude of workshops, safety. Failing to address unprofessional behav- may not speak up about a problem for fear of courses, and degrees have been established to ior in a fair and transparent manner allows such retaliation or humiliation. help hone and refine these skills. The following behavior to persist and signals to new employ- list, though not comprehensive, reviews a few of ees that such behavior may be tolerated, ORGANIZATIONAL CULTURE the most important attributes that distinguish an potentially promoting more of it. Addressing AND EMPLOYEE BURNOUT effective leader from an ineffective one (Table 1). unprofessional behavior in disruptive employ- An organization’s culture can enhance ees can yield improved staff satisfaction and patient safety and drive quality. It can also con- See “Effective Leadership,” Next Page APSF NEWSLETTER June 2020 PAGE 45

Leaders Can Foster Culture that Prevents Clinician Burnout

From “Effective Leadership,” Preceding Page dent making decisions. When leaders hesitate work and work-related sleep loss to be a hazard or become indecisive, as inexperienced lead- in the workplace and has carried out an active Effective Communication ers sometimes do, it can lead to confusion and research program to address this hazard. A Effective communication is necessary to exhaustion among employees. However, every goal of NIOSH’s National Occupational allow an organization’s people to know what is future leader needs a place to start. Profes- Research Agenda (NORA) for Healthcare and expected, valued, and appreciated. Clearly sional development and leadership training for Social Assistance is that health care organiza- articulated goals help people remain focused, high-potential individuals can be of great ben- tions adopt best practices for scheduling and track progress, and discuss challenges openly. efit to organizations. While some may have the staffing that minimize excessive workload and As new ideas are developed, it is critical to skills to be successful as leaders more innately other factors associated with fatigue.14 As the clearly define mission objectives and review than others, not everyone is a natural born cost of health care continues to increase, so do them at regular intervals along the way with all leader. Even those with significant experience the demands on productivity. With continual involved stakeholders, including frontline pro- or professional leadership training may fail. A improvements in information technology, elec- viders, thought leaders, or senior faculty. This study by the Center for Creative Leadership tronic medical records, and machine learning, monitoring of progress with regular checks and showed that roughly 38% to more than half of there is a growing list of tools available to help balances avoids potential miscommunication new leaders fail within their first 18 months.7 improve processes and streamline care so that and assures compliance with intended goals. At Leaders can avoid becoming part of this stagger- increased productivity demands do not always all times, leaders must remain open to construc- ing statistic by incorporating good leadership translate into increased workload. tive criticism and feedback. If this is hindered, strategies that motivate their team members to team members may begin to fear retaliation or accomplish their goals. Openness to feedback, CONCLUSION humiliation for speaking up. checking in regularly with one’s own goals, and Effective leadership in medicine is necessary Collaborative Teamwork recognizing signs of failure are all keys to suc- to promote patient safety. Leaders must con- Fostering a culture of teamwork and camara- cess and continuous improvement. tinually strive to be role models, stewards of resources, and improve processes. Effective derie is essential to building a culture of safety. Adaptability Leaders should take pride in what their provid- leaders support safety initiatives and create It is imperative that leaders work with front- ers have already accomplished while nurturing systems that address concerns brought forth by line providers to develop and implement cre- their skills for further development. The positive frontline providers and patients. Constraints of ative work strategies to maximize efficiency attitude from the leader is instrumental and con- any kind in an organization can lead to while limiting workplace stressors and reducing tagious at the same time. When leaders work increased frustration, communication break- burnout. Increasing pressure continues to together with their frontline providers, it down, and potential errors. In order to remain mount from organizational and third-party empowers them to partner with the vision and efficient and effective, leaders must overcome stakeholders to meet metrics. Some institutions the growth at the highest level. One example of these obstacles and maintain forward thinking, are seeing only a slight increase in volume, yet collaborative teamwork is the sharing of impor- regularly checking in with their employees, the work hours are longer, translating to an tant data metrics. Providers are more likely to ensuring their state of wellbeing, and taking increased risk to the employee’s health with comply with the recurrent demands of work- corrective action when elements become out diminishing returns in productivity. Longer place objectives when given a better under- of balance. By creatively adapting and effec- employee work hours are associated with standing of why they need to do it. Effective tively communicating, leaders can help their increased fatigue, poor mood, poor recovery communication and collaborative teamwork organizations accomplish goals, even in difficult from work, and a nearly 40% increase in risk for are essential in aligning with a common goal. times. Employees with higher job satisfaction at coronary artery disease.10-12 Men and women work have lower rates of burnout, allowing for Experience working long hours showed higher prevalence increased focus, productivity, and fewer overall While experience alone does not make a of and anxiety disorders.13 For medical errors. great leader, experienced leaders may be more decades, the National Institute for Occupational Dr. Trainer is assistant professor of Anesthesiol- comfortable taking chances and more confi- Safety and Health (NIOSH) has recognized shift ogy at Virginia Commonwealth University and Central Virginia VA Health Care System in Rich- Table 1: Key Attributes of Effective Leaders mond, VA. She is also completing a fellowship in Critical Care Medicine with the Department of Anesthesiology and Critical Care at the Univer- EFFECTIVE • Clearly articulates goals and objectives sity of Virginia, Charlottesville, VA. COMMUNICATION • Open to constructive criticism and feedback Dr. Dayal is program director of Pain Medicine in the Department of Anesthesiology and Periop- • erative Care, University of California Irvine, CA, COLLABORATION Fosters a culture of teamwork and camaraderie • Inclusive and nurturing and is an associate clinical professor in the Department of Anesthesia and Perioperative Care, University of California Irvine Medical • Comfortable and confident in their decision-making Center, CA. EXPERIENCE • Maintains forward thinking and the need for continuous Dr. Agarwala is chief medical officer at Massa- improvement chusetts Eye and Ear, faculty anesthesiologist at Massachusetts Eye and Ear and Massachusetts • Implements creative work strategies to streamline care and General Hospital, and assistant professor at ADAPTABILITY maximize efficiences Harvard Medical School, Boston, MA. • Stewards resources and strives to improve processes See “Effective Leadership,” Next Page APSF NEWSLETTER June 2020 PAGE 46

Effective Leadership

From “Effective Leadership,” Preceding Page 3. Joint Commission Sentinel Event Alert. The essential role of 10. Caruso CC, Hitchcock EM, Dick RB, et al. Cincinnati, OH: leadership in developing a safety culture. Joint Commis- Department of Health and Human Services, Public Health sion. Issue 57, March 1, 2017. Service, Centers for Disease Control and Prevention, Dr. Pukenas is vice chair and vice chief of National Institute for Occupational Safety and Health; 2004. 4. Hickson GB, Pichert JW, Webb LE, Gabbe SG. A comple- Administrative Affairs in the Department of Overtime and extended work shifts: recent findings on ill- mentary approach to promoting professionalism: identify- nesses, injuries, and health behaviors. DHHS (NIOSH) Pub- Anesthesiology at Cooper University Health ing, measuring, and addressing unprofessional behaviors. lication No. 2004–143. Acad Med. 2007;82:1040–8. Care and assistant dean for Student Affairs and 11. Siu O-L, Donald I. Psychosocial factors at work and workers’ 5. Tucker A, Singer S. The effectiveness of management by health in Hong Kong: an exploratory study. Bulletin of the associate professor of Anesthesiology at walking around: a randomized field study. Prod Oper Hong Kong Psychological Society. 1995;34/35:30–56. Manag. 2014;25:1977–2001. Cooper Medical School of Rowan University in 12. Virtanen M, Heikkilä K, Jokela M, et al. Long working hours 6. Delizonna, L. High-performing teams need psychological and coronary heart disease: a systematic review and meta- Camden, NJ. safety. here's how to create it. Harv Bus Rev. 2017 Aug. analysis. Am J Epidemiol. 2012;17:586–596. 7. Riddle, D. Executive integration: equipping transitioning 13. Kleppa E, Sanne B, Tell GS. Working overtime is associated The authors have no conflicts of interest. leaders for success. 2016. https://www.ccl.org/wp-content/ with anxiety and depression: the Hordaland health study. uploads/2015/04/ExecutiveIntegration.pdf . Accessed Journal of Occupational and Environmental Medicine. March 5, 2020. 2008;50:658–666. REFERENCES: 8. Kohn LT, Corrigan JM, Donaldson MS, et al. To err is human: 14. NORA Healthcare and Social Assistance Sector Council. building a safer health system. Washington, DC: National State of the sector healthcare and social assistance. Depart- 1. Albright-Trainer B. Leadership philosophy: what makes a Academy Press, Institute of Medicine. 1999. great leader? VSA Update Newsletter. Fall 2019. ment of Health and Human Services, Centers for Disease 9. Tawfik DS, Profit J, Morgenthaler TI, et al. Physician burnout, Control and Prevention, National Institute for Occupational 2. Sfantou D, Laliotis A, Patelarou A, et al. Importance of lead- well-being, and work unit safety grades in relationship to Safety and Health Publication No. 2009–139. http://www. ership style towards quality of care measures in healthcare reported medical errors. Mayo Clin Proc. 2018;93:1571– cdc.gov/niosh/docs/2009-139/pdfs/2009-139.pdf. Accessed settings: a systematic review. Healthcare (Basel). 2017;5:73. 1580. on March 5, 2020.

Misfilling the Exhausted Vaporizer by Jonathan A. Bond, DO, MPH; Charles Barry II, MD, MSE, PE; and Nicole Hollis, DO A 61-year-old male was urgently taken to the operating room for removal of infected pelvic hardware. Shortly after induction, both isoflu- rane and appeared on the display (Figure 1), despite only a sevoflurane vaporizer being attached to the device. The vaporizer was removed after switching to a total intrave- nous anesthetic to avoid the possibility of fur- ther vaporizer inaccuracies. No harm was caused to the patient. After the surgery, biomedical engineers were unable to identify any malfunctioning compo- nents of the anesthesia machine or gas ana- lyzer. The vaporizer was then connected to devices in different operating rooms. Specifi- cally, the vaporizer was attached to Dräger Apollo® and Fabius® machines, and each device produced the same finding; detectable levels of both and sevoflurane. The Figure 1: Dräger gas analyzer display showing both isoflurane and Figure 2: Sevoflurane spe- offending vaporizer was also replaced by a dif- sevoflurane delivery when using an incorrectly filled sevoflurane cific key is able to be forced ferent vaporizer on the original machine and vaporizer. onto an isoflurane bottle. displayed appropriate sevoflurane concentra- tions without any detectable amounts of isoflu- nel change, two spinal occurred directly pouring the contents from one to rane. These findings confirmed that the between the identified cases. Because the con- another, remains a possibility and should be on vaporizer was filled with isoflurane. taminated vaporizer was not used, no alarms the differential if confronted with similar ana- were encountered by the new providers. This Analysis showed the records of six previous lyzer abnormalities. While these events did not allowed the error to persist to an additional result in patient harm, it is our hope that this anesthetics that had measurable amounts of unaware team that inherited the remaining cases. case provides awareness on the persistent isoflurane documented when administering the The anesthesia professionals and technicians assumed solitary anesthetic of sevoflurane. As involved were contacted. No source of cross-con- possibility of misfilled vaporizers. a result, multiple events were identified that tamination with the volatile agents or problems Jonathan A. Bond, DO, MPH, is a CA-2 anesthesi- allowed this error to persist. The initial alarm with refilling the vaporizer were reported. ology resident in the Department of Anesthesiol- identifying the co-administration of the volatile ogy at West Virginia University, Morgantown, WV. agents was thought to be due to the gas ana- The findings were communicated to the lyzer malfunctioning, as there were no isoflu- entire anesthesia department during our Charles Barry, MD, MSE, PE, is an assistant pro- rane vaporizers attached to the machine nor monthly quality improvement conference. fessor in the Department of Anesthesiology at While we were unable to identify the exact were any present in the room. The dismissal of West Virginia University, Morgantown, WV. source, the potential for the incorrect filling of a an alert speaks to the breadth of alarm fatigue vaporizer still exists despite safety controls and Nicole Hollis, DO, is an assistant professor in the caused by frequent, if not constant, audible device specific keys for each volatile agent and Department of Anesthesiology at West Virginia alarms in the operating room. vaporizer. Although rare, circumventing these University, Morgantown, WV. The importance of intraoperative handoffs mechanisms by forcing a sevoflurane adapter cannot be overstated as well. Following a person- onto an isoflurane volatile bottle (Figure 2) or The authors have no conflicts of interest. APSF NEWSLETTER June 2020 PAGE 47

Drug Swaps and Compressed Medical Gases by Sathappan Karuppiah, MD; Roy Kiberenge, MD; and Richard Prielipp, MD

INTRODUCTION: gas mixture. Therefore, we posit that com- Safety standards for compressed medical pressed medical gases should be treated with gases and their labelling and delivery have safety protocols such as standardizing the improved over the last several decades. But design (as well as color coding) of medical gas despite efforts to strengthen standards for label- cylinders, requirements for a more robust label- ing and administration of medications, drug ling system, a redesign of tubing and connec- errors continue to be a leading cause of adverse tors to gas cylinders that prevent “drug swaps,” events among patients undergoing anesthesia.1 and perhaps the addition of oxygen sensors to Misidentification of ampules, vials, and syringes portable gas delivery equipment. is a well-recognized source of drug swap errors. We report a case where carbon dioxide was Following a root cause analysis (RCA) of this administered to a patient from a portable com- event, our institution made the following pressed gas cylinder—instead of oxygen—rap­ - changes to operating room (OR) policy and pro- idly leading to severe hypoxemia during cedures: Figure 1: Standard oxygen E cylinder (left) and a transport. We suggest that compressed medical similar appearing carbon dioxide cylinder (right). 1. We eliminated the need for portable cylinders gases should be classified in the same category of carbon dioxide within the OR environment. as medications. For instance, safety experts now Operating rooms were provided with a central recommend standards for labelling drug pipeline source of carbon dioxide if needed ampoules and vials, as well as a bar code system 2 during cardiac surgery for patients at risk for for drug verification in the operating room. Our air emboli during open heart procedures. case illustrates that similar identification systems and additional fail-safe delivery systems should 2. All carbon dioxide E cylinders with connected be considered with the administration of all por- flow regulators and nipple were removed table medical gases. from the operating theater. 3. Additional education and awareness training CASE DESCRIPTION: is now provided to all anesthesia profession- A 62-year-old female, status post orthotropic als to enhance vigilance during transport of heart transplant complicated by coronary artery critically ill patients. vasculopathy, presented for repeat heart trans- Figure 2: Nearly identical appearing flowmeters but plantation. After anesthesia induction and for a thin carbon dioxide label (right). Dr. Sathappan Karuppiah is an anesthesiology placement of invasive monitoring, the operation resident at the University of Minnesota. was suspended due to problems with the Dr. Roy Kiberenge is assistant professor, Depart- placement of the donor lungs. After hours of that it was actually a carbon dioxide cylinder ment of Anesthesiology at the University of Min- delay, the operation resumed. Re-do cardiac with a regulator, flowmeter and a green admin- nesota. transplantation and separation from cardiopul- istration connector (“nipple”) that can be readily monary bypass proceeded without incident. At connected to oxygen AMBU delivery tubing Dr. Richard Prielipp is professor, Department of the conclusion of surgery, the patient was trans- (Figure 2). The patient was successfully trans- Anesthesiology at the University of Minnesota. ferred from the operating room table to the ported to the ICU and made an uneventful The authors have no conflicts of interest. Richard transport ICU bed. Surprisingly, as the patient recovery. Prielipp is executive section editor of the APSF was connected to our standard Air Mask Bag Executive Committee and Executive Section Editor of Unit (AMBU—Copenhagen, Denmark) with an E DISCUSSION: Patient Safety, Anesthesia & Analgesia. cylinder of (presumed) oxygen (Figure 1), she Medication errors often increase patient became hypotensive with a rapid decrease in morbidity and even mortality.3 Drug (or syringe) REFERENCES: swaps account for nearly 50% of medication 1. Whitaker DK, Wilkinson DJ. Medical gases: time to adopt oxygen saturation (from 99% to 80%). She was the global standard? APSF Newsletter. 2014;29;17–18. immediately reconnected to the anesthesia errors associated with anesthesia professionals https://www.apsf.org/article/medical-gases-time-to-adopt- machine ventilator with FiO2 = 1.0, while small and often result in serious outcomes.2,4 In the the-global-standard/. Accessed October 28, 2019. boluses of vasopressors stabilized her hemo- present case, the substitution of the com- 2. Wahr JA, Abernathy JH 3rd, Lazarra EH, et al. Medication safety in the operating room: literature and expert-based dynamics. After several minutes of stability of all pressed carbon dioxide gas cylinder—mistaken recommendations. Br J Anaesth. 2017;118:32–43. vital signs, a second attempt to ventilate the for an E cylinder of oxygen—represents a drug 3. Kothari D, Gupta S, Sharma C, Kothari S. Medication error in patient with the same AMBU setup began, but swap error.4 While current anesthesia machines anaesthesia and critical care: a cause for concern. Indian J again the patient’s blood pressure and satura- are replete with safeguards and monitors to Anaesth. 2010;54:187–192. prevent delivery of a hypoxic gas mixture 4. Eichhorn JH. Medication mishap mitigation drives 2008 tion quickly declined. After a return to the anes- APSF workshop: “Syringe swaps” in OR still harming thesia machine ventilator, vital signs again during anesthesia, no such standards exist patients. APSF Newsletter. 2008-9;23:57–59. https://www. quickly normalized. At this point, it was decided during transport of a critically ill patient. Indeed, apsf.org/article/syringe-swaps-in-or-still-harming-patients/. to transport the patient with a dedicated ICU this case illustrates how easily conventional Accessed November 6, 2019. 5. Sarangi S, Babbar S, Taneja D. Safety of the medical gas transport ventilator. When the E-cylinder was equipment in the cardiovascular operating pipeline system. J Anaesthesiol Clin Pharmacol. 2018; being removed from the bed, it was discovered room can be assembled and deliver an anoxic 34:99–102. APSF NEWSLETTER June 2020 PAGE 48

When Medical Equipment Standards Fail to Protect Patients by Jeffrey Feldman, MD, MSE

Standards applied to the design of medical equipment have a variety of purposes, with patient safety being paramount. In this issue of the APSF Newsletter, we have two examples where patient safety was threatened using equipment where the standards intended to protect patients proved to be inadequate. Bond and co-authors describe an incident where a sevoflurane vaporizer was misfilled with isoflurane. The result was a mixture of isoflurane and sevoflurane delivered to the patient with the potential for overdosage of the isoflurane. Agent-specific filling systems were adopted many years ago to prevent this type of error. Although the cause of the misfilling is not proven, the authors demonstrate that it is entirely possi- ble to place a keyed sevoflurane filler cap on an isoflurane bottle. In this case, neither the stan- dards for a keyed collar on the bottle nor the color coding were sufficient to prevent misfilling Medical equipment design standards will not equipment but has failed to prevent patient of the sevoflurane vaporizer. The authors are to protect patients 100% of the time. Human error injury numerous times. be congratulated for believing the information remains a factor in causing patient injury. There When standards fail to protect patients, we are numerous examples of properly connected provided by the agent monitor in the absence of are reminded of the importance of monitoring gas tubing yet patient injury from contamination an obvious explanation and making appropriate devices, and vigilance by care providers, to of gas supply lines or compressed gas cylin- changes to patient care. identify when there are problems and intervene ders filled with the wrong gas. The risk of this before there is harm. Both of the reports here Kruppiah and co-authors provide a case problem is one of the motivations for requiring demonstrate the importance of human inter- report of a patient receiving 100% carbon diox- an oxygen analyzer for every anesthetic to vention. That said, we should seek to make our ide via an AMBU bag connected directly to a insure that oxygen is indeed being delivered. standards as robust as possible to minimize the carbon dioxide cylinder. Medical gas cylinders Some standards are however more robust than risk of harm. These case reports show that both are keyed with a pin index system so that they others. The Diameter Index Safety System the standards for anesthetic agent key filling and flowmeters that mount to compressed gas can only be connected to specific yokes. In this (DISS) is designed to insure that gas supply lines are connected properly between the wall cylinders could be improved. It also reminds us case, the pin index system worked as designed, supply and the gas delivery device, e.g., anes- all that no standard or monitor takes the place but the mounted flowmeter (which was labelled thesia machine or ventilator. This standard uses of a vigilant health care professional. Carbon Dioxide) included a green nipple for the diameters of both the internal nozzle and connecting gas supply tubing. The green color Dr. Feldman is professor of Clinical Anesthesiol- external screw connector to insure that gas ogy Children’s Hospital of Philadelphia, Perel- of the nipple indicates an oxygen source, and connections are proper. DISS is a very robust man School of Medicine, University of the design allowed for commonly used oxygen standard in that it is not possible to misconnect Pennsylvania, and chair of the APSF Committee supply tubing to be connected to the flowmeter. gases when using this standard. An older stan- on Technology Again, the standards in place intended to pre- dard, the Pin Index Safety Standard (PISS) is vent patient injury from accidental CO2 adminis- designed for connecting high-pressure medical Dr. Feldman has received consulting compensation tration were insufficient to protect the patient. gas cylinders to a regulator or other ancillary from Micropore, Inc., and Dräger Medical. Get Social With Us!

The APSF is eager to connect with patient safety enthusiasts across the internet on our social media platforms. Over the past year, we have made a concerted effort to grow our audience and identify the best content for our commu- nity. We've seen increases in followers and engagement by several thousand percent, and we hope to see that trajectory continue into 2020. Please follow us on Facebook at http://www.facebook.com/APSForg and on Twitter at www.twitter.com/APSForg. Also, connect with us on Linked In at https://www.linkedin.com/company/anesthesia-patient-safety-foundation-apsf- We want to hear from you, so please tag us to share your patient safety related work, including your academic arti- cles and presentations. We’ll share those highlights with our community. If you are interested in joining our efforts to amplify the reach of APSF across the internet by becoming an Ambassador, please reach out via email to Marjorie Stiegler, MD, our Director of Digital Strategy and Social Media at [email protected], Emily Methangkool, MD, the APSF Ambassador Program Director at [email protected], or Amy Pearson, Social Media Manager at pear- Marjorie Stiegler, MD, APSF Director [email protected]. We look forward to seeing you online! of Digital Strategy and Social Media. APSF NEWSLETTER June 2020 PAGE 49

Cardiopulmonary Sentinel Event During Endoscopic Retrograde Cholangiopancreatography (ERCP): Oversedation or Gas Embolism? by Brian Thomas, JD INTRODUCTION against both the hospital on behalf of the CRNA Gas embolism occurring during endoscopy pro- and the anesthesiologist. All parties accepted the cedures such as endoscopic retrograde cholangi- panel’s awards and the hospital settled for a con- opancreatography (ERCP), where a mucosal fidential amount. With the PPM’s insured anes- membrane is breached is a rare, but potentially thesiologist’s consent, this case was settled for devastating complication that can cause perma- $10,000. nent significant neurological injuries or fatal cardio- DISCUSSION pulmonary collapse.1 Due to its rarity and lack of In GI endoscopy cases, venous gas embolism clinical suspicion, air embolism during gastroenter- (VGE) is caused by gas bubbles, under pressure, ology (GI) endoscopy procedures is often unrec- entering the vasculature allowing the passage of ognized until it is too late for successful treatment.2 was terminated and the patient was taken to the gas into the systemic circulation.3 VGE, including Intensive Care Unit. The difficulty in diagnosing air embolism often intracardiac and intracerebral air embolism, is results in confusing the embolism with inappropri- A neurologist consult noted chronic ischemic highly lethal with a mortality rate of up to 21%, ate anesthetic care, or with an acute ischemic or 4 1 changes in the right parietal-occipital lobe and a according to a recent study. hemorrhagic event. The following case demon- chronic lacunar infarction of the cerebellum on Different mechanisms causing gas entry into strates how a sudden cardiovascular collapse computed tomography. Probable anoxic enceph- the venous system have been proposed: inva- during ERCP due to a suspected, undiagnosed air alopathy was noted on electroencephalogram. sive procedures (e.g., sphincterotomy, biliary embolism resulted in a serious adverse event. The patient never regained any neurologic func- stent), exposure to high gas insufflation pressure, tion and she expired one week postoperatively. CASE STUDY intramural dissection by the gas, and biliary-hep- A 74-year-old, 72.6 kg ASA IV female with past The patient’s husband sued the anesthesia ato-venous fistula. Other identified risk factors for medical history significant for diabetes, chronic team and the hospital alleging the patient was VGE include previous procedures of the bile duct renal failure, transient ischemic attacks, coronary oversedated, which caused cardiopulmonary system, abdominal trauma, metal stent place- artery disease (coronary artery stent placement), depression, PEA arrest, and anoxic brain injury. ment, and digestive system inflammation.5 In a congestive heart failure, hypertension, and The plaintiff’s expert opined that the anes- series of over 800 patients reported on by peripheral vascular disease (status post-below- thetic was “excessive” and the propofol should Afreen et al., the incidence of VGE as docu- knee amputation) presented to the emergency not have been administered. He opined further mented by precordial Doppler ultrasound was department with an abrupt onset of diffuse that when the patient first became bradycardic 2.4% (20/843 patients) of which 10 had significant abdominal pain. The patient was scheduled to and hypotensive, the certified registered nurse hemodynamic alterations. In addition, stent have an ERCP due to her choledocholithiasis, bili- anesthetist (CRNA) should have called the super- removal combined with stent replacement ary obstruction, and abdominal pain. revealed a 4.4% incidence of VGE, while cases vising anesthesiologist, immediately intubated 6 The anesthesia professional conducted the pre- the patient, and administered epinephrine. He during cholangioscopy had a 9.1% incidence. anesthetic evaluation. He additionally noted that was also critical that the supervising anesthesiol- Unexpected cardiovascular events in the GI the patient had significant anxiety. The plan was to ogist was not “carefully and continuously” moni- endoscopy suite, during or at the end of an endos- perform monitored anesthesia care with intrave- toring the CRNA. copy procedure where a mucosal or vascular bar- nous sedation sufficient to enable the procedure. The defense forensic pathology expert did not rier may be or had been breached should alert clinicians to consider gas embolism. In the endoscopy suite, the patient was placed identify any evidence of an anesthetic overdose. in the semi-prone position after electrocardio- Because of the lack of an autopsy and toxicology Brian Thomas, JD, is vice president—Risk Man- gram, blood pressure cuff, pulse oximetry, and reports, there was little evidence to determine agement for Preferred Physicians Medical, a ETCO2 monitoring were applied. She was admin- the exact cause of death. medical professional liability insurance carrier istered 2 mg midazolam, 100 mcg fentanyl, 30 The defense anesthesiology expert was fully that provides malpractice insurance exclusively mg lidocaine, 0.2 mg glycopyrrolate and 15 mg supportive of the care and treatment provided by to anesthesiologists and their practices. propofol intravenously in total for her 30-minute the anesthesiologist and CRNA. He opined that procedure. appropriate doses of anesthesia were utilized in this The author has no conflicts of interest. The endoscopy then began with insertion of the case. The defense expert noted that the CRNA and anesthesiologist responded to the changes in the REFERENCES scope accompanied by insufflation of air to enable 1. Wills-Sanin B, Cardenas YR, Polanco L, et al. Air embolism endoscopic visualization. Approximately five min- blood pressure and heart rate very rapidly. The after endoscopic retrograde cholangiopancreatography in utes into the procedure, the endoscopist noted immediate response to the epinephrine restored a patient with budd chiari syndrome, case reports in critical blood pressure and provided adequate perfusion care 2014; https://doi.org/10.1155/2014/205081 difficulty identifying the major duodenal papilla 2. Goins KM, May JM, Hucklenbrunch C, et al. Unexpected and also documented “a very large peri-ampullary for delivery of oxygen. The expert did not believe cardiovascular collapse from massive air embolism during diverticulum” in that area. A few minutes thereafter, the documented timeline supported the theory of endoscopic retrograde cholangiopancreatography. Acta anoxia from oxygen deprivation. He opined that the Anaest Scand. 2010;54:385–388. the patient became bradycardic and hypotensive. 3. Chandrasekhara V, Khashab MA, Muthusamy VR, et al. The patient’s blood pressure was treated twice patient’s sudden cardiovascular collapse upon Adverse events associated with ERCP. Gastrointest with 10 mg ephedrine, and she was turned supine being turned supine was the result of an air embo- Endosc. 2017;32–47. for mask/bag ventilation. Approximately five min- lism caused by the ERCP procedure and the gastro- 4. McCarthy CJ, Behravesh S, Sailendra N, et al. Air embolism: enterologist’s difficulty finding the hepatopancreatic diagnosis, clinical management and outcomes. Diagnos- utes later, the patient was pulseless with electro- tics. 2017;7:5. cardiogram unchanged. Cardiopulmonary ampulla. The expert cited numerous cases in the 5. Hauser G., Milosevic M, Zelic M, et al. Sudden death after medical literature supporting his causation findings. endoscopic retrograde cholangiopancreatography resuscitation was started with chest compressions, (ERCP)—case report and literature review. Medicine. 1 mg epinephrine was given, the patient was intu- This case was submitted to a mediation panel 2014;93, e235. https://doi.org/10.1097/ bated and a pulse was immediately restored. prior to trial. Following each side’s submission of MD.0000000000000235 6. Afreen LK, Nakayama T, Ness TJ, et al. Incidence of venous Pulse oximeter readings throughout the case their respective briefs and exhibits, the panel air embolism during endoscopic retrograde cholangiopan- ranged from 92 to 100 percent. The procedure awarded the patient’s husband money damages creatography. Anesth Analg. 2018;127:420–423. APSF NEWSLETTER June 2020 PAGE 50

Gas Embolism Events in GI Endoscopy: What We Know Now and How We Can Mitigate Them Through the Routine Use of CO2 Insufflating Gas Instead of Air by Nikolaus Gravenstein, MD, and Brian Thomas, JD

There is an accumulating pulmonary and/or endoscope be higher than venous pressure? absorption of CO2, in the event that gas embo- cardiac adverse event case experience arising The answer is, perhaps surprisingly, very much lism takes place. This recommendation appears out of gastroenterology (GI) endoscopy suites. so. In an in vitro model, it was determined that to be particularly valid for higher risk interven- High morbidity and mortality embolic events the gas pressure at the tip of the endoscope tions including ERCP, cholangioscopy, and have been reported when the insufflating gas may easily exceed 175 or even 300 mmHg endoscopic necrosectomy.”8 from a gastroenterologist’s endoscope enters a depending on the endoscopy system and flow patient’s circulation.1 It is those gas embolism settings.3 This is possible because the GI Dr. Gravenstein is professor of Anesthesiology, events that are often conflated with poor anes- endoscopy system insufflating gas is flow- and Neurosurgery and Periodontology at the Univer- thetic care, and where there is still, in many not pressure-limited. Thus, if there is no place sity of Florida. cases, a demonstrable opportunity to reduce for the insufflating gas to decompress around Brian Thomas, JD, is vice president—Risk Man- harm by using carbon dioxide instead of air as the scope, then the local venous pressure is agement for Preferred Physicians Medical, a the endoscope insufflating gas. We are easily exceeded by the gas pressure which, reminded of this in a recent infographic.2 along with a mucosal or vascular breach (e.g., medical professional liability insurance carrier that provides malpractice insurance exclusively Anesthesia professionals are involved in biopsy, myotomy, ulcer, inflammation, necro- to anesthesiologists and their practices. endoscopy suite cases to enable patient coop- sectomy, dilation, or a stent placement), enables a gas embolism scenario. eration, immobility, and amnesia. These cases The authors have no conflicts of interest. are variably described as monitored anesthesia Not all endoscopy procedures have the care or general anesthesia. We think they are same risk. In purely diagnostic procedures, the REFERENCES: best described as intravenous general anes- risk is indeed negligible. There is a strong argu- 1. Donepudi S, Chavalitdhamrong D, Pu L, et al. Air embolism thetics (drug-induced loss of consciousness ment in favor of making CO the default insuf- complicating gastrointestinal endoscopy: a systematic 2 review. World J Gastrointest Endosc. 2013;5:359–65. during which patients do not arouse during oth- flating gas for all GI endoscopy procedures, erwise painful stimulation), i.e., the patient 2. Wanderer JP, Nathan N. Bubble trouble: venous air embo- because we cannot consistently predict when a lism in endoscopic retrograde cholangiopancreatography. accepts endoscope insertion and manipulation. biopsy will be taken, a mucosal surface to be Anesth Analg. 2018; 127:324. If one accepts the target patient state as one of breached, and the insufflating gas pressure at 3 Bursian A, Gravenstein N, Draganov PV, et al. GI endoscopy at least moderate sedation ranging to general the tip of the endoscope also exceed venous insufflating gas pressure: how regulated is the regulator? anesthesia, expected monitoring includes cap- Paper presented at: International Anesthesia Research pressure. Carbon dioxide insufflated laparo- Society Annual Meeting; May 2016; San Francisco, CA. nography. Capnography in the setting of what scopic surgeries, set a safety precedent for this is often a natural, and in the case of upper 4 Rogers BH. The safety of carbon dioxide insufflation during which we are all familiar with. This is in part, colonoscopic electrosurgical polypectomy. Gastrointest endoscopy procedures also a shared, airway is because CO2 is more readily absorbed and less Endosc. 1974;20:115–117. technically more challenging than in an endo- likely to be lethal than air if it gets into the vascu- 5 Janssens F, Deviere J, Eisendrath P, et al. Carbon dioxide tracheally intubated patient. Nasal cannula lar system. for gut distension during digestive endoscopy: technique and/or oral airway derived capnography makes and practice survey. World J Gastroenterol. 2009;15:1475– it difficult to reliably and quickly identify clinically Using carbon dioxide for GI endoscopy is not 1479. novel. In 1974 it was suggested to use carbon 6 Wang WL, Wu ZH, Sun Q, et. al. Meta-analysis: the use of significant decreases in ETCO2, as would occur dioxide to reduce the risk of explosion with carbon dioxide insufflation vs. room air insufflation for gas- with a gas embolism. In an intubated patient a trointestinal endoscopy. Aliment Pharmacol Ther. 2012;35: 4 drop in ETCO2 is much more obvious and colon polyp cautery. Yet, in a 2008 survey, 1145–1154. unambiguous because there is generally a very fewer than half of the endoscopists reported 7 Afreen LK, Bryant AS, Nakayama T, et al. Incidence of stable ventilation and gas sampling relationship that they were aware that using CO2 for insuffla- venous air embolism during endoscopic retrograde cholan- with every exhaled breath. The vagaries of nat- tion gas was an option for GI endoscopy proce- giopancreatography. Anesth Analg. 2018;127:420–423. 5 8 ASGE Technology Committee, Lo SK, Fujii-Lau LL, Enest- ural airway capnography may obfuscate an oth- dures and <5% used CO2 for insufflation. vedt BK, et al. The use of carbon dioxide in gastrointestinal erwise significant drop in ETCO2. This might Another potential benefit of the CO2 gas use is endoscopy. Gastrointest Endosc. 2016;83:857–865. delay provider recognition of perturbations in that it may cause less postprocedure discom- Additional references: 6 pulmonary blood flow, blood pressure, heart fort than air. Sharma VK, Nguyen CC, Crowell MD, et al. A national study of rate, or oxygen saturation that are associated We as anesthesia professionals should sup- cardio- pulmonary unplanned events after GI endoscopy. Gas- with significant gas embolism. trointest Endosc. 2007;66:27–34. port the use of CO2 insufflating gas during GI Ben-Menachem T, Decker GA, Early DS, et al. Adverse events Clinically significant gas embolization during endoscopic procedures. It is readily available of upper GI endoscopy. Gastrointest Endosc. 2012;76: 7 an endoscopy procedure can happen any time and demonstrably safer. To help persuade 707–18. there is a connection between the insufflating yourselves and gastroenterology colleagues, Ali Z, Bolster F, Goldberg E, et al. Systemic air embolism compli- gas and the vascular system and intraluminal the 2016 American Society for Gastroenterol- cating upper gastrointestinal endoscopy: a case report with pressure is higher than local vascular pres- ogy Technology Committee reported that, post-mortem CT scan findings and review of literature. Forensic Sci Res. 2016;1:52–57. sures. When the venous pressures are gener- “Several authors recommend the use of CO 2 Dellon ES, Hawk JS, Grimm IS, et al. The use of carbon dioxide ally less than 20 mmHg, the natural question to instead of room air as an insufflation agent for insufflation during GI endoscopy: a systematic review. Gas- ask is: Can the gas pressure at the tip of a GI during endoscopy because of the rapid tissue trointest Endosc. 2009;69:843–849. APSF NEWSLETTER June 2020 PAGE 51

Malignant Hyperthermia Preparedness: Stocking, Drilling, and Offsite Considerations by Ryan J. Hamlin, MD, and Mohanad Shukry, MD, PhD

INTRODUCTION having 36 vials available in each institution. If This July marks the 60th anniversary of the Ryanodex® is stocked, MHAUS recommends publication of a Letter to the Editor describing having 3 vials available. Sterile water should be the inherited condition, now known as Malignant stocked alongside the dantrolene in the first Hyperthermia (MH), in a young man who devel- drawer as it is necessary to reconstitute the pow- oped metabolic derangements when exposed dered dantrolene. The amount stocked should to .1 The worldwide scientific commu- reflect the formulation of dantrolene (larger nity has come a long way since then to charac- volume is required for Dantrium®/Revonto® com- terize the condition. We now have a better pared to Ryanodex®). If Dantrium®/Revonto® is understanding of the pathophysiology, presen- the stocked formulation, we would recommend tation, and treatment of this potentially fatal con- stocking thirty-six 100 ml vials of sterile water dition. Although difficult to truly characterize, MH rather than one-liter bags of sterile water to pre- crisis prevalence is estimated to be 1 in 100,000 vent the inadvertent intravenous administration administered anesthetics,2 which means, thank- of a hypotonic solution. Three 10 ml vials of ster- fully, most anesthesia professionals may only ile water can be stocked if Ryanodex® is the participate in a true MH crisis once in their career, stocked formulation. Although clinical effective- access, and a large sterile drape that can be if at all. This fact, coupled with the possible fatal- ness and dosing are similar between the two used to rapidly cover a surgical wound. ity of an MH crisis, makes the preparation to formulations, the lower storage space needed manage these rare events paramount for the for Ryanodex®, the lower number of staff Temperature management of MH patients is safety and good outcome of those patients. needed to mix it and the increased speed of very important as the risk of death increases with 4 We focus on two essential steps in the prep- mixing and administering the loading dose increasing temperature. Following discontinua- aration to manage an MH crisis: stocking a makes Ryanodex® more practical during a crisis, tion of the triggering agent, dantrolene administra- dedicated MH Cart to be used during an acute especially when number of staff available is lim- tion is the most important pharmacologic crisis, and developing an institutional multidisci- ited. temperature management strategy. Noninvasive plinary mock MH drill for anesthesia and oper- treatments for hyperthermia include strategic ice Other medications stocked in the cart should packing, forced air cooling, circulating cool water ating room personnel. Lastly, we discuss the be focused on the treatment of the sequalae of special considerations of MH preparedness for blankets, cold intravenous fluids, and ice-water the hypermetabolic condition, such as severe 6 offsite and remote anesthetizing locations. immersion. An ice bucket, large and small plastic acidemia, hyperkalemia, cardiac arrhythmias, bags for ice, and disposable cold packs can be and severe hyperthermia. Sodium bicarbonate MH CART placed next to the patient easily to help with cool- (8.4% 50 ml vials x 4) should be stocked to aid in ing measures. A pressure bag should also be The Malignant Hyperthermia Association of the correction of severe acidemia. Calcium chloride United States (MHAUS) recommends medica- included for rapid administration of cold saline. 10% (10 ml vials x 2), Dextrose 50% (50 ml vials x tions and supplies be readily available for use, 2), and regular insulin (100 unit/ml 1 vial) should Monitoring equipment should focus on accu- within 10 minutes of recognizing an MH crisis.3 be stocked for treatment of hyperkalemia. Lido- rate and reliable measurements. For temperature Since the likelihood of complications increases 1.6 caine (100 mg/5 ml or 100 mg/10 mls x 3) or amio- monitoring, esophageal or other core (nasopha- times with every 30-minute delay in treatment darone (150 mg vial x 4) should be stocked ryngeal, tympanic, or rectal) temperature probes with dantrolene,4 having a centrally located cart according to ACLS/PALS guidelines for any car- should be considered. Central and arterial lines with the necessary medications and equipment should be considered for critically ill patients and expedites the initiation of treatment. When dan- diac derangements. Refrigerated one-liter saline bags are recommended for cooling (some com- transducer kits should be available. Foley cathe- trolene administration was delayed beyond 50 ters and a urometer are also important for moni- minutes, complication rates increased to 100%.5 mercially available MH carts have a small refrig- erator for saline and insulin, but every institution toring urine output to insure adequate diuresis to The organization of the MH cart should be can decide on this matter). prevent acute renal injury from myoglobinurea. divided into two main categories; (1) medications The last category of equipment is laboratory and (2) supplies necessary for an MH crisis. Supplies within the MH cart should be focused on the administration of MH medications, tem- supplies. Frequent laboratory testing is per- There are many commercially available MH formed in a MH crisis and the laboratory testing carts offered for purchase. Regardless of the perature management, patient monitoring, and laboratory testing. Central location of equipment equipment should be readily available and type of cart use, however, dantrolene is the crux labeled for use. Equipment for blood gas mea- of the treatment of MH and should be the easi- can provide a quicker response and more coor- dinated care. Syringes (60 ml x 5) to dilute Dant- surement capability such as heparinized blood est to access (preferably located in the top gas syringes or syringes for point of care testing drawer). Currently two formulations of dan- rium®/Revonto® or (5 ml x 3) for Ryanodex® should be located close to dantrolene. Two pairs should be included. Blood specimen tubes for trolene exist. Dantrium®/Revonto® is the older creatinine kinase, myoglobin, comprehensive formulation, which provides 20-mg dantrolene of activated charcoal filters (Vapor-Clean™, Dyn- metabolic panel (Na+, K+, Ca+, BUN, HCO,3 sodium in 60 mL following reconstitution in ster- asthetics, Salt Lake City, UT) should be included. Mg+), lactate, complete blood count, and coag- ile water USP. The second formulation, Ryano- These filters attach to the inspiratory and expira- ulation studies should be easily accessible. dex®, is a new formulation that is an injectable tory ports of the anesthesia machine to quickly Lastly, a collection device for urine with testing suspension of dantrolene sodium providing 250 reduce the concentration of gas (<5ppm). Two supplies for myoglobin should be considered. mg of dantrolene sodium in 5 mL following pairs are recommended as the filters may Myoglobinuria can be quickly screened for by reconstitution with sterile water USP. Selection become saturated after one hour of use and a the presence of pigmenturia and blood on a between the two formulations should dictate replacement could be needed. Other patient how many vials should be stocked. If Dantrium®/ care equipment includes intravenous catheters urine dipstick, if available in your institution, and Revonto® is stocked, MHAUS recommends of various sizes for intravenous and arterial See “Malignant Hyperthermia,” Next Page APSF NEWSLETTER June 2020 PAGE 52

MHAUS Recommends Yearly MH Drills

From “Malignant Hyperthermia,” Preceding administration of dantrolene during transport gencies, such as cardiac arrest and anaphylaxis. Page and for a formalized face-to-face transfer of With such events, successful management care with the receiving team. depends upon the presence of well-established should be followed up with a formal urinalysis protocols for early recognition and prompt treat- As mentioned before, MHAUS recommends and quantitative urine myoglobin level. ment. Office-based anesthesia professionals MH drills every year, but these authors perform it also need to consider the relatively remote nature in their institution every 6 months to keep infor- MOCK MH DRILL of the practice when establishing their malignant mation relatively fresh with the staff. Another The utility of medical simulation is well dem- hyperthermia protocol. Dantrolene treatment consideration is to rotate between scheduled onstrated and its application to rare medical delay increased complications every 10 minutes, and unscheduled drills. If the purpose of the drill events can improve familiarity while providing reaching 100% with a 50-minute delay.9 hands-on experience.7 Each facility is different is to assess readiness, there is no better way in their training options, but MHAUS recom- than an unexpected drill. This is obviously more As a patient safety organization, MHAUS mends teams perform mock MH drills every time-consuming, but may be more effective. contends the availability of dantrolene allows 8 clinicians to administer succinylcholine for life- year; we provide a few tips to maximize the Following any simulated drill, it is important to team’s benefit from these valuable exercises. threatening airway emergency without delay have a debriefing session. Debriefing allows due to fear of patients developing MH without team members to discuss what went well and Selection of a clinical scenario should be the only known antidote immediately available. based on the applicability to the team and orga- what could be improved. Debriefing also acts nization. It would not be worthwhile to use a as an opportunity to clarify any lingering ques- CONCLUSION tion team members may have. It is also an scenario of an elderly patient if the team solely Early recognition and treatment of MH is opportune time to discuss the importance of provides care for pediatrics, for example. The essential to improve survival rates. Stocking a contacting the North American MH Registry of development of a scenario is best drawn from dedicated MH cart, routinely performing simu- MHAUS at 888-274-7899 for all confirmed or prior experiences inside the organization; oth- lated MH crisis drills, and having enough dan- suspected MH cases to assist in completing an erwise, commercially available ones can be trolene stocked can save lives. used. Besides the selection of the scenario, online form (AMRA) in order to capture valuable selecting a leader or facilitator is also a critical MH data. All debriefings should be done in a Dr. Hamlin is an assistant professor in the decision. Managing an MH crisis is a team sport safe and nonjudgmental way. Lastly, it is impor- Department of Anesthesiology at the University and everyone needs to engage and participate. tant to develop a contingency plan. What if an of Nebraska and Children’s Hospital & Medical By selecting an anesthesia professional to lead MH crisis happens in the middle of the night? Center Omaha, NE. these drills, participants’ buy-in improves since Who else can be deployed to assist? Will some- Dr. Shukry is a professor & vice chairperson of most health care providers look to anesthesia one be called in? Those questions need to be Pediatric Anesthesiology in the Department of personnel for guidance during an MH crisis. discussed and ironed out before an actual Anesthesiology at University of Nebraska and crisis. The training during a mock MH drill should Children’s Hospital & Medical Center Omaha, NE. focus on two main aspects: rapid recognition of OFFSITE/REMOTE PREPAREDNESS Drs. Hamlin and Shukry are volunteer Hotline MH signs and symptoms and the logistics of The growth of free-standing surgical facilities Consultants for MHAUS coordinating the clinical management team. using only intravenous anesthesia techniques Once the diagnosis is made, the leader should without inhalational agents has increased REFERENCES assign roles to participants based on skill levels. steadily. In an effort to contain cost, MHAUS 1. Denborough MA, R Lovell R. Anesthetic deaths in a family. If personnel resources are limited, such as in a was requested to reconsider the recommenda- Lancet. 1960;2:45. surgery center for example, staff may need to 2. Brady JE, Sun LS, Rosenberg H, Li G. Prevalence of malignant tions related to dantrolene stocking at centers hyperthermia due to anesthesia in New York State, 2001-2005. handle multiple roles. The danger of only that only have succinylcholine for emergency Anesth Analg. 2009;109:1162. assigning one role to a participant is that when airway management. The request is related to 3. Stocking MH Cart. Malignant Hyperthermia Association of the an actual MH crisis occurs, that person may not United States website. https://www.mhaus.org/faqs/category/ the perceived infrequent use of succinylcho- frequently-asked-questions-about/stocking-an-mh-cart/ be in the facility. line, the low incidence of MH susceptibility in Accessed February 24, 2020. Once roles are clearly delineated, the drill the general population, and the cost of stocking 4. Larach, MG, Brandom, BW, Allen, GC, et al. Malignant hyperther- mia deaths related to inadequate temperature monitoring, should focus on the logistics of providing care dantrolene. 2007–2012: A report from the North American Malignant Hyper- in an MH crisis rather than physically treating thermia Registry of the Malignant Hyperthermia Association of As of today, MHAUS recommends facilities the United States. Anesth Analg. 2014;119:1359–66 the patient. For example, the insertion of lines that stock and have the potential to administer 5. Riazi S, Larach MG, Hu C, et al. Malignant hyperthermia in and a Foley catheter should not be the focus. any triggering agent, including succinylcholine Canada: characteristics of index anesthetics in 129 malignant Rather, the focus should be on locating the MH hyperthermia susceptible probands. Anesth Analg. 2014;118:381– without volatile agents, should have dantrolene 387 cart, contents of the MH cart, who is reconstitut- immediately available in the event a patient in 6. Litman RS, Smith VI, Larach MG, et al. Consensus statement of ing dantrolene, who is getting ice, who is calling that facility develops MH.6 In contrast, the Soci- the Malignant Hyperthermia Association of the United States on the MH Hotline, etc. If available, the team unresolved clinical questions concerning the management of ety for Ambulatory Anesthesia (SAMBA) Position patients with malignant hyperthermia. Anesth Analg. 2019;128: should reconstitute an expired vial or two of Statement on the Use of Succinylcholine for 652–659. dantrolene, especially if the institution uses the Emergency Airway Rescue permits class B facili- 7. Henrichs BM, Avidan MS, Murray DJ, et al. Performance of certi- 20 mg/60 ml formulation, as this process is very fied registered nurse anesthetists and anesthesiologists in a ties to stock succinylcholine for airway rescue simulation-based skills assessment. Anesth Analg. 2009;108: laborious. without dantrolene in situations where no volatile 255–262. 9 8. MHAUS Knowledge Base. https://www.mhaus.org/cfw/index. In a surgery center, the drill should include a agents are used. Larach et al. demonstrated cfm?controller=kb&action=view-article&key=3B6A48A5- post-stabilization transport plan. This is crucial succinylcholine administered in the absence of 5056-A852-6BAC-E4538FD554F9&seoTitle=mh-training-fre- to have in place before an actual MH episode volatile agents, over a wide dose range to quency. Accessed April 27, 2020. 9. Joshi GP, Desai MS, Gayer S, Vila H. Succinylcholine for emer- occurs. Depending on how far the facility is, we manage difficult ventilation, can trigger MH gency airway rescue in class B ambulatory facilities. Anesth recommend, whenever staffing allows, an events that warrant dantrolene treatment.10 This Analg. 2017;124:1447–1449. anesthesia professional, from the transferring report shifts the consideration of succinylcholine- 10. Larach MG, Klumpner TT, Brandon BW, et al. on behalf of the Mul- ticenter Perioperative Outcomes Group. Succinylcholine use and or receiving facility, accompany the patient to induced MH from the realm of highly unlikely into dantrolene availability for malignant hyperthermia treatment. the receiving hospital to allow for the continued the realm of similarly rare but devastating emer- Anesthesiology. 2019;130:41–54. APSF NEWSLETTER June 2020 PAGE 53

Educating the Next Generation: A Curriculum for Providing Safe Anesthesia in Office-Based Surgery by Brian M. Osman, MD, and Fred E. Shapiro, DO, FASA

INTRODUCTION Table 1. Key Studies Addressing Safety in Office-Based Anesthesia Prior to 2010* In 1979, fewer than 10% of all surgeries were performed as outpatient procedures. In just Key Papers, Year Method Finding about 25 years, approximately 70% of opera- Hoefflin et al, 20018 23,000 cases from single No significant complications. tive procedures have evolved beyond the walls plastic surgery office of hospitals, with 15–20% occurring in office- Vila et al, 20037 2 years of adverse events 10-fold relative risk in office compared based practices.1 In 1985, the Society for Ambu- reported to Florida board with ASC. latory Anesthesia (SAMBA) was founded as a Koch et al., 20039 Compared 896 office-based No systemic complications reported in national society with a mission statement to vs. 634 hospital-based the office-based group. intraocular procedures “strive to be the leader in the perioperative care performed from 1983 to 1986 of the ambulatory surgical patient.” Their focus 10 includes anesthesia in the ambulatory setting, Perrot et al, 2003 >34,000 oral and maxillofacial Complication rate of 0.4%–1.5% for all surgeries types of anesthesia. non-operating room anesthesia (NORA) and 11 office-based anesthesiology (OBA), patient Byrd et al, 2003 5316 cases from single plastic Complication rate 0.7% (mostly surgery office hematoma) care, medical education, patient safety, research, and practice management.2 Fleisher et al., 200412 Evaluated Medicare patients 1-week mortality rates in the office, (age >65 years), more than half ASC, and hospital as 0.035%, 0.025%, As office-based anesthesia became more a million outpatient procedures and 0.05% of outpatient procedures, popular, SAMBA recognized the importance of from 1994 to 1999. respectively. keeping education initiatives current and pub- Bhananker et al., Reviewed closed malpractice > 40% of MAC claims involved death or lished an anesthesia resident educational cur- 200613 claims in the ASA Closed permanent brain injury. Respiratory Claims Database since 1990 depression accounted for 21% of riculum designed to provide a comprehensive claims, half of which preventable by experience in the anesthetic management of better monitoring. ambulatory surgical patients in an office-based Coldiron et al, 200814 Self-reported data to Florida 174 adverse events; 31 deaths in this environment. The evolution of this curriculum board from 2000 to 2007 time frame. began in 2006 with Dr. Fred Shapiro creating Keys et al., 200815 1,141,418 outpatient procedures 23 deaths observed. PE was the cause the first Harvard Medical School office-based performed at AAAASF facilities of 13 of those deaths. Office-based anesthesia Continuing Medical Education abdominoplasty most commonly (CME) course, ”The Manual of Office-Based associated with death from PE. Anesthesia Procedures,” presented to the Abbreviations: ASC – Ambulatory Surgical Center; ASA – American Society of Anesthesiologists; AAAASF – Academy at Harvard Medical School, which led American Association for Accreditation of Ambulatory Surgery Facilities; MAC – Monitored Anesthesia Care; DVT – deep vein thrombosis; PE – pulmonary embolism; to the inception of an OBA curriculum, and was later incorporated into the SAMBA national pro- *Adapted with permission from: Shapiro FE, Punwani N, Rosenberg NM, et al. Office-based anesthesia: safety and outcomes. Anesth Analg. 2014;119:276–85. gram. In 2010, Dr. Shireen Ahmad and Dr. Fred Shapiro co-authored the SAMBA Anesthesia the last 25 years. There was a lack of uniform greatly improved. Shapiro et al. concluded in OBA Curriculum, which was reviewed by the reporting of adverse events in the office setting 2014 that this was likely due to proper creden- SAMBA taskforce on Ambulatory and Office- and also a lack of randomized controlled trials tialing of facilities and practitioners, increased Based Anesthesia, approved by the SAMBA to determine how office-based procedures and accreditation, adherence to national societies Board of Directors, and added to the website.3 anesthesia affect patient morbidity and mortal- guidelines, the incorporation of safety check- It was designed to be an educational guide for 5 ity. As a result, studies on this topic are retro- lists, and the implementation of additional over- a one-month specialty rotation during the final spective in nature. Some of the early literature sight at both state and federal levels.5,16 Table 2 (CA-III) year of residency in Anesthesiology. expressed concerns about the safety of office- Since its initial inception in 2010, the number, highlights some of the important OBA literature based procedures and anesthesia. A 2001 from 2010 to 2019. complexity, and variety of cases in the office- study by Domino et al. examined the reported based anesthesia environment has experi- complications in the American Society of Anes- In 2017, Gupta et al. analyzed a large data- enced exponential growth. There have been thesiologists (ASA) Closed Claims Database base of over 183,914 cases from 2008 to 2013 many changes to the literature, practice man- and reported that office-based claims were and concluded that complication rates in Office agement, accreditation requirements and approximately three times more severe than Based Surgery Center (OBSC), ASCs, and hos- office-based practice legislation, and the new Ambulatory Surgery Centers (ASCs).6 Vila et al. pitals were 1.3%, 1.9%, and 2.4%, respectively.20 2020 curriculum update strives to be consis- This demonstrated that, at least for cosmetic 4 concluded in 2003 that the relative risk of com- tent with current standards of safe practice. plications and death was 10 times greater in the procedures, accredited office-based surgery 7 UPDATE TO THE LITERATURE office-based practices compared to ASCs. centers were a safe alternative to ASCs and 2010 TO 2020 Other important studies prior to 2010 are listed hospitals. Overall, anesthesia and surgery in in Table 1 and demonstrated mixed results. To better understand the trajectory of OBA, it the office is becoming increasingly safe and the is important to demonstrate a general knowl- The literature since 2010 suggests that recent data suggest that it is attributable to edge of how the literature has changed over patient safety and outcomes in the office have See “Office Based Anesthesia,” Next Page APSF NEWSLETTER June 2020 PAGE 54

Implementing Safe Office-Based Anesthesia Practices

From “Office Based Anesthesia,” Table 2. Key Studies Addressing Safety in Office-Based Anesthesia After 2010* Preceding Page Key Papers, Year Method Finding proper patient and procedure selection, as well 17 1,21 Twersky et al, 2013 Review of ASA Closed Outcomes did not differ between groups, with as adhering to adequate safety protocols. Claims Data from 1996- death in 27% and permanent disabling injury in Patients treated in the office seem to be 2011 17% of OBA claims. selected based on their low risk for complica- 18 1 Soltani et al, 2013 AAAASF data from 2000– 22,000 of 5.5 million cases; complication rate tions. As the popularity of OBA continues to 2012; only reviewed 0.4%; 94 deaths; 0.0017% death rate. increase, different systematic approaches have plastic surgery offices been developed to promote the standardiza- Failey et al, 201319 2611 cases from single No deaths, cardiac events, transfers; 1 DVT tion of safe practices. These include published AAAASF facility under guidelines and position statements, emergency TIVA/conscious sedation protocols, safety checklists, medication man- Shapiro et al, 20145 Comprehensive literature Improvements in patient outcomes likely with agement and surgical risk reduction, new regu- review credentialing, accreditation, safety checklists, 21 state and federal regulation, and national lations and accreditation measures. societies. PRACTICE MANAGEMENT Gupta et al, 201720 Compared outcomes of Complication rates in OBSC, ASCs, and 183,914 plastic surgery hospitals were 1.3%, 1.9%, and 2.4%, The OBA curriculum highlights system-based procedures in accredited respectively. Multivariate analysis showed practice changes relevant to the office environ- facilities lower risk in OBSC when compared to ASCs or ment in 2020. Ultimately, anesthesia profes- a hospital. sionals are responsible for ensuring an Young et al, 20188 Literature review and 2018 Rates of complications from the latest adequate standard of care and should thor- update publications are similar to or lower than oughly inspect the office-based practices they previously reported. The number of primary literature reports is increasing, both agree to work in, taking into consideration the retrospective and prospective. administration, facility engineering, equipment, Seligson et al, 20191 Updated review of the Anesthesia and surgery in the office is and facility accreditation. In 2010, Kurrek and literature from 2017 to becoming increasingly safe, likely due to Twersky responded to this by publishing a pro- 2019 increased patient selection. vider checklist highlighting common elements De Lima et al, 201921 Updated review of the OBA safe with proper patient selection and that should be reviewed before providing anes- literature from 2016 to adequate safety protocols. Current regulations thesia services in an office-based practice.24 2019 are focused on reducing surgical risk through the implementation of patient safety protocols As the demand for OBA continues to increase, and practice standardization. Strategies additional efforts have come forward to pro- include cognitive aids for emergencies, safety checklists, facility accreditation standards. mote patient safety. Since 1999, the ASA has continued to offer general recommendations Osman et al, 201922 Safe anesthesia for office- 72% of the 16.4 million cosmetic procedures based plastic surgery: performed in 2016 were performed in the for proper patient and procedure selection, as proceedings from the office. As of 2018, only 33 states have well as insisting on the presence of medical Korean society of plastic guidelines, policies, or position statements directors responsible for policies that adhere to and reconstructive regarding OBS, makes gathering outcome current regulations, adequately trained and cre- surgeons 2018 meeting data difficult. dentialed health care providers, and facility Osman et al, 201923 A comprehensive review A review of the literature, updates on patient compliance with local and national legislation.25 and 2019 update to OBA safety, patient and procedure selection, practice management, accreditation, quality These guidelines were amended in 2009, reaf- improvement programs, and legislations and firmed in 2014, and have contributed to the cre- regulations. ation of other important recommendations such Abbreviations: ASA – American Society of Anesthesiologists; OBA – office-based anesthesia; ASC – AAAASF - as the Guidelines for Ambulatory Anesthesia American Association for Accreditation of Ambulatory Surgery Facilities; TIVA – total intravenous anesthesia; OBSC (reaffirmed in 2018), and a multi-disciplinary col- – office-based surgery center; ASC - Ambulatory Surgical Center; OBA – Office-based anesthesia ; OBS-Office- based surgery; DVT-deep venous thrombosis. laboration (ASA, American Association of Oral *Adapted with permission from: Shapiro FE, Punwani N, Rosenberg NM, et al. Office-based anesthesia: safety and and Maxillofacial Surgery, American College of outcomes. Anesth Analg. 2014; 119:276-85. Radiology, American Dental Association, Amer- ican Society of Dentist Anesthesiologists, Soci- Office-Based Surgery and can be found at reviewed the most common emergencies spe- ety of Interventional Radiology) to create the https://www.ashrm.org/. These types of safety cific to the office and published an OBA emer- 2018 Practice Guidelines for Moderate Proce- checklists have shown promise in the literature gency manual in 2017 to provide a concise and dural Sedation.25,26 for the reduction of medical errors and the user-friendly resource tool with treatment algo- In 2010, the Institute for Safety in Office-Based improvement of patient safety and outcomes.27,28 rithms. This emergency manual is based on Surgery (ISOBS) created a patient safety check- principles from widely accepted crisis manuals list adapted from the World Health Organization With the continued growth of office-based (advanced cardiovascular life support, Malig- (WHO) Surgical Safety Checklist, customizable to surgery, staff and practitioners should have nant Hyperthermia Association of the United the office-based practice. In 2017, the ISOBS easy access to critical information to assist with Office-Based Surgery Checklist (Figure 1) was crisis management. The use of cognitive aids, States, Stanford, Massachusetts General Hospi- added to the American Academy of Healthcare tailored to the office-based practice, can prove tal), and it offers algorithms for 26 of the most Risk Management (ASHRM) resource manual for to be effective in emergency situations. ISOBS See “Office Based Anesthesia,” Next Page APSF NEWSLETTER June 2020 PAGE 55

Safety Checklists Are Designed for Office-Based Surgery

From “Office Based Anesthesia,” defined, the evidence supports success with as steroids, pregabalin, NSAIDs, acetaminophen, Preceding Page general anesthesia, total intravenous anesthesia clonidine, intravenous lidocaine, and intraopera- (TIVA), local anesthesia with moderate sedation, tive injection of long-acting liposomal bupiva- common emergency scenarios in the OBA and conscious sedation.10,11,19 As of 2020, there caine.23 Improved pain control can be achieved 21 practice. As of 2018, this manual is available are new concepts and improved methods of while reducing the opioid-related side effects. on the Emergency Manuals Implementation patient care. For example, Enhanced Recovery Collaborative (EMIC) website (https://www. After Surgery (ERAS) techniques, such as multi- Other useful tools include decision aids emergencymanuals.org/). modal therapies and non-opioid-based periop- developed to incorporate the patient in the erative analgesia, can be utilized to enhance the decision-making process regarding their own Another practice management consideration patient perioperative experience by reducing anesthetic and surgical plan. These educa- with the 2020 update to the SAMBA Office- postoperative pain, postoperative nausea and tional tools can easily be applied to the office Based Anesthesia Curriculum was to provide an vomiting (PONV), opioid pain medication use, setting and are another important aspect of evidence-based review of anesthesia tech- and length of stay for inpatient procedures and ERAS. The ASA, for example, has several patient- 23 niques to improve outcomes and patient satis- same-day surgery. Multimodal therapies and centric decision aids available on their web- faction while mitigating risk during office-based non-opioid-based perioperative analgesia are site, which includes decision aids for epidural procedures. Several studies prior to 2010 con- some of the key components of ERAS. These and spinal anesthesia and peripheral nerve cluded that procedures could safely be per- include procedure appropriate regional blocks, formed in the office and, although not clearly oral and intravenous non-opioid adjuncts such See “Office Based Anesthesia,” Next Page

Figure 1. Institute for Safety in Office-Based Surgery Safety Checklist for Office-Based Surgery* Abbreviations: AED – automated external defibrillator; DVT – deep vein thrombosis; EMS – emergency medical services; MH – malignant hyperthermia; NPO – nothing by mouth. *Adapted with permission from: WHO Surgical Safety Checklist. Courtesy of the Institute for Safety in Office-Based Surgery [ISOBS], Inc., Boston, MA. Developed by Alex Arriaga, MD, Richard Urman, MD, MBA, and Fred Shapiro, DO. APSF NEWSLETTER June 2020 PAGE 56

Office Based Surgery Legislation Seeks to Standardize Safe Office-Based Practices From “Office Based Anesthesia,” Preceding law that regulated facilities that perform OBS.30 7. Vila H Jr., Soto R, Cantor AB, Mackey D. Comparative outcomes analysis of procedures performed in physician offices and Page There remained 17 states that did not require ambulatory surgery centers. Arch Surg. 2003:138:991–995. blocks, and is currently developing one for adverse event reporting at that time, but several 8. Hoefflin SM, Bornstein JB, Gordon M. General anesthesia in Monitored Anesthesia Care .29 high-profile cases resulting in death or severe an office-based plastic surgical facility: a report on more than injury found their way to the public through 23,000 consecutive office-based procedures under general These are valuable resources to guide patients anesthesia with no significant anesthetic complications. Plast media reports.23 In 2020, one of the major Reconstr Surg. 2001;107:243–251. through the process of making informed deci- accreditation agencies (The Joint Commission) 9. Koch ME, Dayan S, Barinholtz D. Office-based anesthesia: an sions and participating as an active member of actively monitors state legislative and regula- overview. Anesthesiol Clin North America. 2003;21:417–243. the health care team. 10. Perrott DH, Yuen JP, Andresen RV, Dodson TB. Office-based tory activities, and provides a quick reference ambulatory anesthesia: outcomes of clinical practice of oral tool on their website to review state specific and maxillofacial surgeons. J Oral Maxillofac Surg. ACCREDITATION requirements (https://www.jointcommission.org/ 2003;61:983–995. The three major nationally recognized 11. Byrd HS, Barton FE, Orenstein HH, et al. Safety and efficacy in an accreditation-and-certification/state-recogni- accredited outpatient plastic surgery facility: a review of 5316 accrediting organizations that govern office- 31 tion/). The ultimate focus of OBS legislation is to consecutive cases. Plast Recontr Surg. 2003;1122:636–641. based practices include the Accreditation Asso- increase accountability and standardize safe 12. Fleisher LA, Pasternak LR, Herbert R, Anderson GF. Inpatient ciation for Ambulatory Health Care (AAAHC), practice in office-based anesthesia and surgery. hospital admission and death after outpatient surgery in The Joint Commission (TJC), and American elderly patients: importance of patient and system character- istics and location of care. Arch Surg. 2004;139:67–72. Association for Accreditation of Ambulatory CONCLUSION 13. Bhananker SM, Posner KL, Cheney FW, et al. Injury and liabil- Surgery Facilities (AAAASF).23 All three of these An update to the SAMBA Office-Based Anes- ity associated with monitored anesthesia care: a closed agencies have similar requirements for accredi- claims analysis. Anesthesiology. 2006;104:228–234. thesia Curriculum was essential as office-based tation, but there are some subtle differences. 14. Coldiron BM, Healy C, Bene NI. Office surgery incidents: what surgery and anesthesia has experienced expo- seven years of Florida data show us. Dermatol Surg. Kurrek and Twersky have a 2010 publication 2008;34:285–291. 24 nential growth over the last 25 years. There have that highlights some of these key differences. 15. Keyes GR, Singer R, Iverson RE, et al. Mortality in outpatient Over the past 10 years, accreditation agencies been many changes to the literature, practice surgery. Plast Reconstr Surg. 2008;122:245–250. have recognized some of the patient safety management, accreditation requirements, and 16. Young S, Shapiro FE, Urman RD. Office-based surgery and patient outcomes. Curr Opin Anaesthesiol. 2018;31:707–712. issues in OBS and have focused greater atten- OBA legislation. With the increase in procedures, 17. Twersky R, Posner KL, Domino KB: Liability in office-based anes- tion to the office. There are currently 33 states complexity, and variety of cases, and the contin- ued lack of uniform regulation and legislation in thesia: closed claims analysis. Anesthesiology. A2078, 2013. that require offices that perform medical and 18. Soltani AM, Keyes GR, Singer R, et al. Outpatient surgery and surgical procedures to obtain accreditation, and the office-based practice, there is a need to sequelae. Clin Plast Surg. 2013;40:465–473. this number is expected to increase in the maintain the educational curriculum consistent 19. Failey C, Aburto J, de la Portilla HG, et al. Office-based outpa- with the most recent safe practices and stan- tient plastic surgery utilizing total intravenous anesthesia. future. It is important for the resident to be famil- Aesthet Surg J. 2013;33:270–274. dards. The 2020 update to the curriculum is iar with these three agencies and what accredi- 20. Gupta V, Parikh R, Nguyen L, et al. Is office-based surgery tation means to an office-based practice, as it deliberately presented as goal-driven and is not safe? comparing outcomes of 183,914 aesthetic surgical pro- cedures across different types of accredited facilities. Aes- provides valuable information about how a facil- prescriptive in nature. The OBA practice is dynamic, fluid, and rapidly changing, and we thet Surg J. 2017;37:226–235. ity cares for their patients. Some examples 21. De Lima A, Osman BM, Shapiro FE. Safety in office-based include important issues about how a facility is present the evidence to maintain standards to anesthesia: an updated review of the literature from 2016 to maintained, personnel and their qualifications, support the best practices as of 2020. 2019. Curr Opin Anaesthesiol. 2019;32:749–755. 22. Osman BM, Shapiro FE. Safe anesthesia for office-based infection control, cleaning and maintenance of Dr. Osman is assistant professor in the Depart- plastic surgery: proceedings from the Korean society of plas- equipment, emergency preparedness, creden- ment of Anesthesiology, Perioperative Medicine tic and reconstructive surgeons 2018 meeting. Arch Plast Surg. 2019;37:317–331. tialing and privileging, documentation (i.e., and Pain Management, UHealth Tower, Univer- 23. Osman BM, Shapiro FE. Office-based anesthesia: a compre- HIPAA), and quality improvement, among sity of Miami Miller School of Medicine, Miami, FL. hensive review and 2019 update. Anesthesiol Clin. 2019; others. Accreditation of office-based facilities 37:317–331. allows a third party to monitor activities, provide Dr. Shapiro is associate professor of Anaesthesia, 24. Kurrek MM, Twersky RS. Office-based anesthesia: how to start external benchmarking, validation, and Department of Anesthesia, Critical Care and Pain an office-based practice. Anesthesiol Clin. 2010;28:353–367. Medicine, Beth Israel Deaconess Medical Center, 25. Guidelines for office-based anesthesia. American Society of acknowledgement of a nationally recom- Anesthesiologists. 2018. Available at: https://asahq.org/stan- mended standard of care. Harvard Medical School, Boston, MA. dards-and-guide-lines/guidelines-for-office-based-anesthe- sia. Accessed Mar. 4, 2020. The authors have no conflicts of interest. 26. Practice guidelines for moderate procedural sedation and LEGISLATION analgesia 2018: a report by the American Society of Anesthe- There have been significant changes to siologists Task Force on moderate procedural sedation and REFERENCES office-based legislation in the last 25 years, analgesia, the American Association of Oral and Maxillofacial 1. Seligson E, Beutler SS, Urman RD. Office-based anesthesia: Surgeons, American College of Radiology, American Dental going from almost completely unregulated to an update on safety and outcomes (2017-2019). Curr Opin Association, American Society of Dentist Anesthesiologists, some form of mandated legislation or regula- Anaesthesiol. 2019; 32:756–761. and Society of Interventional Radiology. Anesthesiology. 2018;128:437–479. tion in all 50 states and the District of Columbia. 2. About us: our mission, our vision, our goal. The Society for Ambulatory Anesthesia (SAMBA) 2020. Available at: https:// 27. Rosenberg NM, Urman RD, Gallagher S, et al. Effect of an OBS legislation falls primarily on the individual sambahq.org/about-us/. Accessed Feb. 27, 2020. office-based surgical safety system on patient outcomes. states, which regulate OBS practices with a 3. Ahmad S, Shapiro FE. Society for Ambulatory Anesthesia Eplasty. 2012;12:e59. wide degree of variability. Some states may not Office-Based Curriculum. The Society for Ambulatory Anes- 28. Robert MC, Choi CJ, Shapiro FE, et al. Avoidance of serious thesia (SAMBA) 2010. Available at: https://samba.socious. medical errors in refractive surgery using a custom preopera- require an OBS practice to register or obtain com/p/cm/ld/fid=72. Accessed Mar. 2, 2020. tive checklist. J Cataract Refract Surg. 2015;41:2171–2178. facility licensure (answering to the respective 4. Osman BM, Shapiro FE. Society for Ambulatory Anesthesia 29. Resources from ASA Committees. American Society of Anes- state’s medical licensing board), while other Office-Based Anesthesia Revised 2020 Curriculum. The thesiologists. 2020 Available at: https://www.asahq.org/stan- Society for Ambulatory Anesthesia (SAMBA) 2020. Available dards-and-guidelines/resources-from-asa-committees. states require that office-based practices regis- at: https://samba.memberclicks.net/assets/2019%20Curricu- Accessed Mar. 4, 2020. ter with the department of health or practitio- lum%20Update_Corrected3.pdf. Accessed Mar. 2, 2020. 30. Office-Based Surgery Laws. The Policy Surveillance Program: ner’s licensing board. More stringent states may 5. Shapiro FE, Punwani N, Rosenberg NM, et al. Office-based A LawAtlas Project. 2016. Available at: http://lawatlas.org/ hold offices to the same standard as ASCs or anesthesia: safety and outcomes. Anesth Analg. datasets/office-based-surgery-laws. Accessed Mar. 13, 2020. 2014;119:276–85. 31. State Recognition. The Joint Commission. 2020. Available at: hospitals. As of August 1st, 2016, only 24 states 6. Domino, KB: Office-based anesthesia: lessons learned from https://www.jointcommission.org/accreditation-and-certifica- and the District of Columbia had at least one the Closed Claims Project. ASA Newsletter. 2001;65:9–11,15. tion/state-recognition/. Accessed Mar. 13, 2020. APSF NEWSLETTER June 2020 PAGE 57 Anesthesia Patient Safety Foundation Founding Patron ($500,000) American Society of Anesthesiologists (asahq.org)

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Community Donors (includes Specialty Organizations, Anesthesia Groups, ASA State Component Societies, and Individuals) Specialty ASA State Wyoming Society of Daniel J. Cole, MD Kathleen Connor, MD Della M. Lin, MD Emily Sharpe, MD (in honor of Organizations Component Societies Anesthesiologists Jeffrey B. Cooper, PhD Jeremy Cook, MD Kevin and Janice Lodge Mark Warner) $5,000 to $14,999 $5,000 to $14,999 $200 to $749 Mrs. Jeanne and Dr. Robert A. Dennis W. Coombs, MD Michael Loushin Mary Shirk Marienau Indiana Society of Cordes American Academy of Arkansas Society of Christian David Cunningham Francie Lovejoy Saket Singh, MD Anesthesiologists Anesthesiologists Thomas Ebert, MD Anesthesiologist Assistants Paul Brunel Delonnay Fredric Matlin, MD Ms. Sandra Kniess and David Minnesota Society of David M. Gaba, MD and Colorado Society of John K. DesMarteau, MD Edwin Mathews, MD Solosko, MD $2,000 to $4,999 Anesthesiologists Deanna Mann Anesthesiologists Andrew E. Dick, MD Stacey Maxwell Society for Ambulatory Tennessee Society of James D. Grant, MD, MBA Marjorie A. Stiegler, MD Hawaii Society of Karen B. Domino, MD Gregory McComas, MD Anesthesia Anesthesiologists Anesthesiologists Steven B. Greenberg, MD Shepard B. Stone, DMSc, PA Richard P. Dutton, MD, MBA Sharon Merker, MD Society of Academic $2,000 to $4,999 Maine Society of Dr. Eric and Marjorie Ho Steven L. Sween, MD Donation Elizabeth Drum (in honor of Tricia Meyer, PharmD Associations of Anesthesiology Arizona Society of Anesthesiologists Allen Hyman, MD (in honor of (in honor of Drs. Mary Ellen and Rediet Shimeles, MD) Michael D. Miller, MD and Perioperative Medicine Anesthesiologists Mississippi Society of Robert Epstein, MD) Mark Warner) Mike Edens and Katie Megan Randall D Moore, DNP, MBA, The Academy of California Society of Anesthesiologists Catherine Kuhn, MD James F. Szocik, MD Steven B. Edelstein CRNA Anesthesiology Anesthesiologists New Hampshire Society of James Lamberg, DO Mary Ann and Jan Ehrenwerth, Sara Moser (in honor of Jeffrey Joseph W. Szokol, MD (in honor Massachusetts Society of Anesthesiologists Meghan Lane-Fall, MD, MSHP $750 to $1,999 MD B. Cooper, PhD) of Steven Greenberg, MD) Anesthesiologists New Jersey State Society of American Dental Society of Kathleen Leavitt and Johan David E Eibling, MD Paul Terna, MD Anesthesiologists Suyderhoud David Murray, MD Anesthesiology Michigan Society of Jeffrey Feldman, MD, MSE Anesthesiologists New Mexico Society of David P. Maguire, MD Jay Nachtigal, MD Brian J. Thomas, JD American Society of Dentist Anesthesiologists Cynthia A. Ferris, MD New York State Society of Patty Mullen Reilly, CRNA Emily Natarella Ellen and Butch Thomas Anesthesiologists North Dakota Society of Steven Frank Anesthesiologists Mark C. Norris, MD John B. 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Gilmour, MD Frank Overdyk, MD Christopher Viscomi, MD Anesthesiologists Virginia Society of Lynn Reede, CRNA Michael Greco, PhD, DNP, Amy Pearson, MD (in honor of Anesthesia Groups District of Columbia Society of Anesthesiologists Drs. Ximena and Daniel Sessler CRNA Drs. Mark Warner, Marjorie Siva Sai Voora $5,000 to $14,999 Anesthesiologists Stephanie Wolfe Heindel Linda K Groah, MSN, RN, FAAN Stiegler, Emily Methangkool, Matthew B. Weinger, MD Individuals David P. Martin, & Ms. Sara Associated Anesthesiologists Florida Society of Allen N. Gustin, MD James M. West, MD $15,000 and Higher $200 to $749 Moser) Envision Physician Services Anesthesiologists Arnoley Abcejo, MD Alexander Hannenberg, MD (in John Williams Steven J. Barker, MD, PhD honor of Mark A. Warner) Dhamodaran Palaniappan, MD North American Partners in Georgia Society of Aalok Agarwala, MD, MBA G. Edwin Wilson, MD Anesthesioloigsts $5,000 to $14,999 Gary and Debra Haynes Lee S. Perrin, MD Anesthesia Daniela Alexianu, MD Illinois Society of Mary Ellen and Mark A. Warner John F. Heath, MD Cathleen Peterson-Layne, PhD, Kenneth A. Wingler, MD NorthStar Anesthesia Shane Angus, AA-C Anesthesiologists (in honor of Alan D. Sessler, MD) Genie Heitmiller MD Legacy Society Douglas R. Bacon, MD, MA (in PhyMed Healthcare Group Iowa Society of Hoe T. Poh, MD $2,000 to $4,999 honor of Mark Warner) Thomas Hennig, MD (in honor https://www.apsf.org/ Students of CWRU's Master of Anesthesiologists Susan E. Dorsch, MD of R K Stoelting, MD) Paul Preston, MD Science in Anesthesia, DC Marilyn L. Barton (in memory of donate/legacy-society/ Kentucky Society of James M. Pepple, MD Darrell Barton) Steven K. Howard, MD Richard C. Prielipp, MD Location Anesthesiologists Karma and Jeffrey Cooper Robert K. Stoelting, MD William A. Beck, MD Mark Hudson, MD Aaron N. Primm, MD Missouri Society of Burton A. Dole, Jr. $2,000 to $4,999 Joyce Wahr, MD (in honor of Adam K. Jacob, MD Neela Ramaswamy, MD Anesthesiologists Sarah Bodin, MD Dr. John H. and Mrs. Marsha Madison Anesthesiology Mark Warner) Rebecca L. Johnson, MD Roberta Reedy, DNSc, CRNA Mark D. Brady, MD, FASA Eichhorn Consultants, LLP Nebraska Society of Robert E. Johnstone, MD Christopher Reinhart, CRNA Anesthesiologists, Inc. $750 to $1,999 Amanda Brown (in memory of Mark C. Kendall, MD (in honor of Drew Emory Rodgers, MD (in David and Deanna Gaba $750 to $1,999 Sean Adams, MD Rhonda Alexis) Ohio Society of Joseph W. Szokol, MD) honor of Dr. Fred Spies, MD) Drs. Joy L. Hawkins and Anesthesiologists Donald E. Arnold, MD, FASA Bryant Bunting, DO Anesthesia Associates of James Kindscher David Rotberg, MD Randall M. Clark Oklahoma Society of Douglas A. Bartlett (in memory Edward Cain, MD Kansas City Kevin King, DO Dr. Eric and Marjorie Ho Anesthesiologists of Diana Davidson, CRNA) Matthew W Caldwell Steven Sanford, JD TeamHealth Gopal Krishna, MD Dr. Ephraim S. (Rick) and Ellen Oregon Society of Casey D. Blitt, MD Amy Carolyn Amy Savage, MD $200 to $749 Siker Anesthesiologists Raymond J. Boylan, Jr, MD Jeff Carroll, CAA Ruthi Landau, MD James William Schlimmer (in Anesthesia Associates of South Carolina Society of Amanda Burden, MD (in honor Marlene V. Chua, MD Kathryn Lauer, MD memory of John Tinker, MD) Robert K. Stoelting, MD Columbus, GA Anesthesiologists of Jeffrey Cooper, PhD) David Cohen (in memory of Joshua Lea, CRNA Brence A. Sell, MD Mary Ellen and Mark Warner Department of Anesthesia, NYC Washington State Society of Fred Cheney, MD (in honor of Rhonda Alexis) Sheldon Leslie Jeffrey Shapiro, MD Matthew B. Weinger, MD and Health + Hospitals/Harlem Anesthesiologists Robert Caplan, MD) Jerry A. Cohen, MD Cynthia A. Lien, MD Deepak Sharma, MD Lisa Price Note: Donations are always welcome. Donate online (https://www.apsf.org/donate/) or mail to Anesthesia Patient Safety Foundation, P.O. Box 6668, Rochester, MN 55903. (Donor list current as of April 1, 2019–June 1, 2020.) APSF NEWSLETTER June 2020 PAGE 58

The Anesthesia Professional’s Role in Opioid Stewardship by Adam C. Adler, MD, and Arvind Chandrakantan, MD, MBA

INTRODUCTION Health care professional-prescribed have played a significant role in the growing opioid epidemic. In 2017, more than 70,000 drug-related deaths occurred in the United States with over 47,000 a result of opioids.1 Opioid-related deaths have surpassed deaths related to breast cancer, gun violence, and automotive accidents (Table 1). According to the National Institutes of Health, the yearly esti- mated cost of the opioid epidemic exceeds $78.5 billion including the costs of health care, lost productivity, addiction treatment, and crimi- nal justice-related expenses.1 A significant driver of the opioid addiction issues relates to medically prescribed opioids. Specifically, examination of perioperative Table 1: Comparison of Death Rates Table 2: Perioperative suggestions to opioid prescribing suggests a fair degree of Amongst Common Causes in the enhance opioid safety and perform risk both indiscretion and overprescribing. One United States assessment study suggests that as many as 80% of opioid- Cause of Death Death per Deaths • Screen patients for previous opioid use naïve adult patients filled a prescription for opi- (year) reported per and abuse oids following low-postoperative-pain-risk year day surgical procedures (e.g., carpal tunnel release, • Identify family members at risk for opioid Opioids (2017) 47,6001 130 laparoscopic cholecystectomy, inguinal hernia abuse repair, or knee arthroscopy).2 Additionally, Breast Cancer 41,487* 113 (2016) • Educate patients and families on the dan- between 2004–2008, the mean number of gers of unsecured household opioids doses prescribed increased following these Firearms (2017) 39,773† 109 • Discuss proper disposal methods for opi- low-risk procedures.2 A study of 88,637 opioid- Automotive 36,560‡ 100 oids following the acute pain period naïve adolescents and young adults ages Accidents 13–21 years undergoing surgery revealed that (2018) • Invite discussion with perioperative pre- 4.8% continued to fill prescriptions for opioids *CDC data 2016: https://gis.cdc.gov/Cancer/USCS/ scribers using nonopioid adjuncts as well 90 days following low-risk surgery.3 DataViz.html as careful consideration on the number of †NHTSA: https://www.nhtsa.gov/traffic-deaths-2018 doses prescribed. HEALTH CARE PROFESSIONALS AND ‡CDC: https://www.cdc.gov/nchs/fastats/injury.htm THE UNINTENDED CONSEQUENCES OF OPIOID PRESCRIPTIONS 2000–2015, there were 188,468 cases of opi- tive use of opioids is associated with an Opioids prescribed by health care profes- oid-related exposures reported to the National increase in the following perioperative compli- sionals have resulted in a significant number of Poison Data System in persons < 20 years of cations: respiratory failure, surgical site infec- opioid-related toxicity cases in children.4 From age.4 Children most at risk were those between tions, need for mechanical ventilation, ages 0–5 years and adolescents ages 12–17 pneumonia, myocardial infarction, postopera- years with small children at risk of accidental tive ileus or other gastrointestinal events, and exposures and adolescents at risk of deliberate an increase in all-cause mortality.7 Additionally, ingestion.4 Pediatric opioid related exposures preprocedural long-term opioid use by a family have resulted in > 3600 pediatric critical care member has been associated with persistent unit admissions between 2004–2015.5 opioid use in opioid-näive adolescents and Unused opioids following surgery endanger young adults following surgical and dental pro- 8 adult and pediatric patients by allowing for non- cedures for which opioids are prescribed. therapeutic use as well as accidental ingestion. While it is unclear as to who is consuming A meta-analysis of studies reviewing postsurgi- these opioids (patient vs. family member), it cal opioid prescriptions suggested that 42–71% suggests that physicians should be screening of opioid tablets went unused.6 The vast major- patients prior to prescribing opioids to poten- ity of these unused opioids are often stored in tially mitigate the long-term use of them by the home unsecured and serve as a source for either group. abuse and misuse.6 Health care professionals may have a unique opportunity during the perioperative period to Figure 1: Process of opioid stewardship from education A study of adults undergoing orthopedic sur- to retrieval. gical procedures suggested that the preopera- See “Opioid Stewardship,” Next Page APSF NEWSLETTER June 2020 PAGE 59

Opioid Stewardship From “Opioid Stewardship,” Preceding Page discharge in this project with hopes to under- 2020 address critical issues pertaining to opioid stew- stand pediatric prescribing on a larger scale. APSF Trainee ardship (Table 2). Anesthesia professionals typi- cally screen patients for recent illness, smoking, CONCLUSION Quality Improvement and illicit drug use. During the perioperative Efforts have been taken to reduce the prescrib- (TQI) Recognition period, they may also be able to ascertain the ing of opioids while tracking prescriptions through opioid risk by inquiring about the patient’s per- implementation of individual state prescription Program sonal opioid history as well as those in the monitoring programs. Anesthesia professionals patient's home that may be at risk for abuse or are uniquely positioned to address opioid-related safety issues during the perioperative period. We SRNA and AA Graduate Students misuse. Additionally, the anesthesia encounter Project submission deadline: provides the opportunity to educate patients on may be able to reduce patient exposure by identi- August 17, 2020 at 5:00 PM CDT the dangers of opioids and the requirement for fying patients at risk, educating patients and fami- proper storage and disposal. lies on safe opioid storage, and disposal and The APSF Committee on Education and advocating for appropriate dosing. Training announces the fifth annual APSF OUR OWN EXPERIENCE IN COMBATING Trainee Quality Improvement Program. The THE OPIOID CRISIS REFERENCES 1. Scholl L, Seth P, Kariisa M, et al. Drug and opioid-involved 2020 program will host tracks for student At our institution, we recently completed an overdose deaths - United States, 2013–2017. MMWR. registered nurse anesthetists and anesthesi- initiative to combat the opioid crisis by combin- 2018;67:1419–1427. ologist assistant graduate students. The ing patient and family education with a simple 2. Wunsch H, Wijeysundera DN, Passarella MA, Neuman MD. Opioids prescribed after low-risk surgical procedures in the APSF invites all US anesthesia professionals method for families to dispose of their unused United States, 2004-2012. JAMA. 2016;315:1654–1657. 9 in these two training categories to demon- medication. This project involved providing a 3. Harbaugh CM, Lee JS, Hu HM, et al. Persistent opioid use pre-addressed and postage-paid envelope for among pediatric patients after surgery. Pediatrics. strate their program’s work in patient safety patients to return their unused opioids, followed 2018;141:e20172439 and QI initiatives. The APSF will accept up to 4. Allen JD, Casavant MJ, Spiller HA, et al. Prescription opioid two completed submissions from each US- by an automated reminder email two weeks exposures among children and adolescents in the United postoperatively. This was combined with States: 2000–2015. Pediatrics. 2017;139 :e20163382. based training program. 5. Kane JM, Colvin JD, Bartlett AH, Hall M. Opioid-related criti- patient and parental education on safe storage More information and details on the submis- and disposal. This pilot had 64 of 331 partici- cal care resource use in US children's hospitals. Pediatrics. 2018;141:e20173335 sion process are listed on the APSF website pants return unused opioids with a total of 6. Bicket MC, Long JJ, Pronovost PJ, et al. Prescription opioid (APSF TQI Program Award). Additionally, nearly 3000 mg of oral equivalents commonly unused after surgery: a systematic removed from these homes (Figure 1). For those review. JAMA Surgery. 2017;152:1066–71. please email any inquiries to [email protected]. 7. Menendez ME, Ring D, Bateman BT. Preoperative opioid The top three projects in each track will that returned opioids, the median rate of return misuse is associated with increased morbidity and mortality was 58% (interquartile range = 34.7%–86.1%) of after elective orthopaedic surgery. Clin Orthop Relat Res. receive APSF recognition and financial the amount prescribed. Demographic variables 2015;473:2402-12. rewards of $1,000, $500, and $250, respec- 8. Harbaugh CM, Lee JS, Chua KP, et al. Association between associated with increased likelihood for return long-term opioid use in family members and persistent tively. Winners will be notified in late Septem- of medication were Caucasian, married, and opioid use after surgery among adolescents and young ber and announced on the APSF, AANA, and holding a postgraduate degree. At present we adults. JAMA Surgery. 2019;154:e185838. AAAA websites. 9. Adler AC, Yamani AN, Sutton CD, et al. Mail-back envelopes are working with our pharmacy team to enroll for retrieval of opioids after pediatric surgery. Pediatrics. all perioperative patients receiving opioids at 2020;145:e20192449

NEWASA/APSF Quality Join the #APSFCrowd! Improvement Abstract Donate now at https://apsf.org/FUND Award Program Anesthesia Residents Project submission deadline: June 30, 2020 at 11:59 PM ET APSF and ASA are collaborating in 2020 on a separate Quality Improvement Abstract Award program. Information on how to submit QI abstracts to the ASA The Anesthesia Patient Safety Foundation is launching our first-ever Annual Meeting can be found at ASA crowdfunding initiative, defined as raising small amounts of money MCC/QI Submission Guidelines. The top abstracts will receive both ASA and APSF from a large number of people. recognition and financial awards. Just $15 can go a long way to reach our goals. Abstracts invited to be presented at a vir- tual session will be notified in September. The winners will be chosen after the pre- Help support the vision that “no one shall be harmed by sentations and announced on the APSF anesthesia care.” and ASA websites. APSF NEWSLETTER June 2020 PAGE 60

Safety and Utility of Nitrous Oxide for Labor Analgesia by David E Arnolds, MD, PhD, and Barbara M Scavone, MD

This article pertains to non-COVID-19 patient care. There is currently insufficient information about the cleaning, filtering, and potential for aerosolization associated with use of nitrous oxide for labor analgesia in the setting of the ongoing COVID-19 pandemic. As such the Society for Obstetric Anesthesia and Perinatology reported that, “individual labor and delivery units should discuss the relative risks and benefits and consider suspending use.” https://soap.org/education/provider-education/ expert-summaries/interim-considerations-for-obstetric-anesthesia-care-related-to-covid19/.

Nitrous oxide was discovered in 1772, first side effects of nitrous oxide, which include used as an in the 1800s, and has been nausea, dizziness, sedation, and a sense of incorporated into anesthetic practice for over 150 claustrophobia from the mask.14 Nitrous oxide years. It is a colorless, non-pungent, poorly solu- irreversibly inhibits the vitamin B-12 dependent ble gas with minimal metabolism and rapid onset enzyme methionine synthase, which has key and offset. Nitrous oxide’s anesthetic action is roles in the folate and S-adenosyl methionine mediated by noncompetitive inhibition of the (SAM) cycles. Concerns exist regarding the NMDA receptor, and its analgesic action is potential hematologic, neurologic, and cardio- thought to be mediated through supraspinal acti- vascular risks associated with nitrous oxide use vation of opioidergic and noradrenergic neu- in general anesthesia,1 although the bulk of the rons.1 While not sufficient to serve as a sole agent available evidence supports the overall safety for general anesthesia, it possesses analgesic of nitrous oxide in most settings and popula- and anxiolytic properties at sub-anesthetic tions.2 Nitrous oxide exposure has rarely been doses, and is useful as a component of general associated with subacute combined degener- anesthesia and for procedural and dental seda- used in contemporary obstetric analgesia, such ation of the spinal cord in vitamin B12 or folate 2 15 tion. Nitrous oxide is used for management of as methoxyflurane10 or sevoflurane,11 making deficient patients, and known vitamin B-12 or labor pain in many parts of the world, although interpretation of the degree of pain relief rela- folate deficiency is a contraindication to nitrous significant geographic variation exists. In the tive to modern analgesic strategies challenging. oxide use. Unfortunately, levels are not rou- United Kingdom, for example, nitrous oxide is A recently conducted systematic review con- tinely checked during pregnancy, despite the used by 50–75% of women, and use is also cluded that evidence regarding the effective- fact that up to 29% of women in the third tri- 3 16 common in Finland, Australia, and New Zealand. ness of nitrous oxide for labor analgesia is mester may have vitamin B-12 insufficiency. In contrast, until recently, nitrous oxide labor anal- insufficient or of low strength.4 Establishing the Testing for B-12 and folate levels or avoiding gesia was extremely rare in the United States; as degree of labor pain relief provided by nitrous nitrous oxide should be considered for patients of 2014, nitrous oxide was known to be in use for oxide is an area ripe for future research. at elevated risk for vitamin B-12 or folate defi- management of labor pain at only five United ciency, such as those following a vegan diet or States centers.4 Since that time and concomitant Many women are satisfied with nitrous oxide, with extensive bowel resections. with the introduction of FDA-approved devices even if they report that it does not provide good pain relief.12 Nitrous oxide has known nonanal- Nitrous oxide at high concentrations has the for self-administration of a blended mixture of potential to cause diffusion hypoxia, although gesic effects, such as anxiolysis, which may be 50% N2O and 50% O2, interest in the use of this would not be expected to occur with the valued by some women, and qualitative analy- nitrous oxide for labor analgesia in the United commonly used mixture of 50% O /50% N O.4 sis of women’s experience with nitrous oxide 2 2 States has rapidly increased, and at least 500 Nitrous oxide is also contraindicated for during labor suggests that these nonanalgesic centers in the United States are thought to cur- patients who require supplemental O therapy, and partial analgesic effects contribute to 2 rently offer nitrous oxide for labor pain manage- either for maternal oxygen desaturation or for 5 maternal satisfaction.5 These findings highlight ment. While anesthesia professionals in the intrauterine fetal resuscitation. Finally, nitrous that pain relief is not the only driver of satisfac- United States are familiar with the use of nitrous oxide is a recreational drug of abuse with seri- tion with anesthetic care during labor and deliv- oxide in the operating room, the rapid introduc- ous consequences from long-term use,17 and tion of nitrous oxide in obstetrics has raised ques- ery and point to the complexities of the labor 13 the possibility of an increased future risk for tions about the utility and safety of nitrous oxide and birth experience. Nitrous oxide may be of recreational abuse in women first exposed to 6,7 in this setting. These concerns are primarily particular benefit to women who place more nitrous oxide for labor analgesia has not been centered around the effectiveness of nitrous value on the ability to freely ambulate during studied. In summary, while labor nitrous oxide oxide for labor analgesia, as well as ensuring labor, the sense of control resulting from use of is generally considered safe for the mother maternal, fetal, and occupational safety. a self-administered, noninvasive agent, or non- and is not known to have significant effects on analgesic effects than on maximal pain relief. 3,18 Epidural analgesia is the most effective form labor progress, mothers must be screened Nitrous oxide may also be valuable for women of pain relief in labor. Compared to the wealth of for known contraindications to nitrous oxide who prefer to avoid neuraxial analgesia and data on the effectiveness of neuraxial analgesia use to minimize maternal risk. parenteral opioids as part of a birth plan, or who or parenteral opioids, there is relatively little have contraindications to neuraxial analgesia. Fetal concerns surrounding maternal nitrous regarding the degree of pain relief provided by oxide utilization include the possibility of imme- nitrous oxide. Much of the available data sug- A key consideration in the use of nitrous diate neonatal effects as well as the potential gests a modest analgesic effect at best. One oxide for labor analgesia focuses on ensuring for long-term hematopoietic or neurodevelop- study found no decrease in pain scores with maternal safety. Nitrous oxide can expand air- mental sequalae. While nitrous oxide freely nitrous oxide compared to placebo in early filled spaces, and conditions such as a recent crosses the placenta, the rapid offset of nitrous 8 labor, and use of nitrous oxide did not lead to a pneuomothorax or inner ear or retinal surgery oxide predicts a limited immediate neonatal significant decrease in pain scores in a recent represent contraindications to nitrous oxide use effect, and studies examining short-term out- study in the United States.9 Several studies on (Table 1). While these conditions are rare on comes such as umbilical cord gases and Apgar the effectiveness of nitrous oxide for labor pain labor and delivery, they must be considered. relief have included comparators that are not Patients should be counseled regarding known See “Nitrous Oxide,” Next Page APSF NEWSLETTER June 2020 PAGE 61

Parturients Should Be Appropriately Screened Before Using Nitrous Oxide

From “Nitrous Oxide” Preceding Page exhaled gases, occupational exposure to nitrous The authors have no conflicts of interest. scores have not found any evidence of short- oxide during labor and delivery can exceed rec- ommendations.21 Scavenging requires not only term adverse neonatal outcomes associated REFERENCES: with maternal nitrous oxide use.3,4 Thus, while appropriate equipment, but also that the patient 1. Sanders RD, Weimann J, Maze M. Biologic effects of nitrous intrapartum nitrous oxide does not appear to have exhale into a tight-fitting mask. Even some centers oxide: a mechanistic and toxicologic review. Anesthesiol- ogy. 2008;109:707–722. immediate adverse neonatal consequences, the utilizing appropriate scavenging are not able to 2. Buhre W, Disma N, Hendrickx J, et al. European Society of long-term effects are unknown. In adults, nitrous achieve compliance with recommended occupa- 22 Anaesthesiology Task Force on Nitrous Oxide: a narrative oxide exposure for greater than 6 hours as part of tional exposure limits. It is clear that a monitoring review of its role in clinical practice. Br J Anaesth. a general anesthetic inhibits hematopoiesis,19 but plan is a key component of safe nitrous oxide 2019;122:587–604. implementation on labor and delivery. 3. Rosen MA. Nitrous oxide for relief of labor pain: a systematic no similar studies have been done in the immedi- review. Am J Obstet Gynecol. 2002;186:S110–S126. ate neonatal period. Neurologic toxicity in the In summary, the use of nitrous oxide for labor 4. Likis FE, Andrews JC, Collins MR, et al. Nitrous oxide for the form of subacute combined spinal cord degener- analgesia is rapidly expanding in the United management of labor pain: a systematic review. Anesth ation has been reported only in the setting of pro- Analg. 2014;118:153–167. States. The history of nitrous oxide use in this 5. Richardson MG, Raymond BL, Baysinger CL, et al. A qualita- longed recreational abuse, in the setting of rare setting in other countries, as well as limited tive analysis of parturients’ experiences using nitrous oxide congenital disorders, or in patients that are vitamin experience in the United States, suggests that it for labor analgesia: it is not just about pain relief. Birth. 1,2 2019;46:97–104. B-12 or folate deficient. In addition, nitrous oxide is likely safe for the mother, neonate, and for acts at the NMDA receptor, and NMDA receptor 6. King TL, Wong CA. Nitrous oxide for labor pain: is it a laugh- those who work on labor and delivery. Rigorous ing matter? Anesth Analg. 2014;118:12–14. antagonists have been associated with neuro- evidence demonstrating this, however, is lack- 7. Vallejo MC, Zakowski MI. Pro-con debate: nitrous oxide for apoptosis in the developing brain in animal ing and should be a research priority. The avail- labor analgesia. Biomed Res Int. 2019;2019:4618798–12. 20 models in a time- and agent-dependent fashion. ability of nitrous oxide is not a substitute for 8. Carstoniu J, Levytam S, Norman P, et al. Nitrous oxide in Nitrous oxide as a sole agent has not been linked early labor. Safety and analgesic efficacy assessed by a 1 neuraxial analgesia, and 40%–60% of women double-blind, placebo-controlled study. Anesthesiology. to neuroapoptosis, and the relevance of these who initially choose nitrous oxide later convert 1994;80:30–35. animal models to pediatric anesthesia or anes- to neuraxial analgesia.9,12 Furthermore, the 9. Sutton CD, Butwick AJ, Riley ET, et al. Nitrous oxide for labor analgesia: utilization and predictors of conversion to neur- thetic agents administered in pregnancy has not introduction of nitrous oxide did not change the been established and is widely debated. No stud- axial analgesia. J Clin Anesth. 2017;40:40–45. neuraxial labor analgesia utilization rate in one 10. Jones PL, Rosen M, Mushin WW, et al. and ies on neurologic toxicity or sequalae have been center.23 The impact of nitrous oxide labor anal- nitrous oxide as obstetric analgesics. II. A comparison by conducted in neonates of mothers utilizing nitrous gesia on the general anesthesia rate for intra- self-administered intermittent inhalation. Br Med J. oxide in labor, although the lack of case reports of 1969;3:259–262. partum cesarean delivery has not been neurotoxicity despite the long history of nitrous 11. Yeo ST, Holdcroft A, Yentis SM, et al. Analgesia with sevoflu- investigated. Women choosing nitrous oxide in rane during labour: II. Sevoflurane compared with Entonox oxide use in labor worldwide may be somewhat labor should be screened for possible contrain- for labour analgesia. Br J Anaesth. 2006;98:110–115. reassuring. The influence of nitrous oxide on 12. Richardson MG, Lopez BM, Baysinger CL, et al. Nitrous dications and counseled appropriately regard- either short- or long-term neonatal outcomes in oxide during labor: maternal satisfaction does not depend ing the expected modest analgesic effects, side exclusively on analgesic effectiveness. Anesth Analg. premature infants, who may be particularly vulner- effects, and particularly the uncertainty regard- 2017;124:548–553. able to any potential adverse effects of nitrous ing the long-term effects of fetal exposure. 13. Hodnett ED. Pain and women's satisfaction with the experi- oxide, has not been examined. The rapid offset of ence of childbirth: a systematic review. Am J Obstet Gyne- Additional research into these important ques- nitrous oxide mitigates potential concerns about col. 2002;186:S160–S172. tions should be a priority. Finally, appropriate 14. Richardson MG, Lopez BM, Baysinger CL. Should nitrous its transfer into breast milk, although the influence, patient education, scavenging, and monitoring oxide be used for laboring patients? Anesthesiol Clin. if any, of intrapartum nitrous oxide use on the initia- 2017;35:125–143. is essential to prevent potential toxicity from tion of breastfeeding is unknown. In summary, 15. Patel KK, Munne JC, Gunness VRN, et al. Subacute com- nitrous oxide use in labor does not appear to have occupational exposure. bined degeneration of the spinal cord following nitrous oxide anesthesia: a systematic review of cases. Clin Neurol immediate neonatal adverse effects, but the Neurosurg. 2018;173:163–168. potential for long-term impact on the neonate has Table 1: Contraindications to Nitrous 16. Sukumar N, Rafnsson SB, Kandala N-B, et al. Prevalence of not been well studied. vitamin B-12 insufficiency during pregnancy and its effect Oxide Use for Labor Analgesia on offspring birth weight: a systematic review and meta- In addition to concerns regarding maternal Absolute Relative analysis. Am J Clin Nutr. 2016;103:1232–1251. and neonatal safety, the use of nitrous oxide 17. Garakani A, Jaffe RJ, Savla D, et al. Neurologic, psychiatric, Pneumothorax Risk for B-12 or folate and other medical manifestations of nitrous oxide abuse: a during labor and delivery raises occupational systematic review of the case literature. Am J Addict. Recent retinal surgery deficiency (i.e., vegan safety concerns. These concerns have been diet, history of bowel 2016;25:358–369. driven primarily by retrospective survey data Middle ear or sinus resection) 18. Rooks JP. Safety and risks of nitrous oxide labor analgesia: infection a review. J Midwifery Womens Health. 2011;56:557–565. suggesting the possibility of an increased risk of Recent opioid 19. O'Sullivan H, Jennings F, Ward K, et al. Human bone spontaneous abortion and/or low birth weight Pulmonary administration Hypertension marrow biochemical function and megaloblastic hemato- among women with occupational exposure to Acute intoxication poiesis after nitrous oxide anesthesia. Anesthesiology. nitrous oxide.1 While there is no clear evidence Vitamin B-12 or folate 1981;55:645–649. deficiency Requirement for supplemental O 20. Vutskits L, Xie Z. Lasting impact of general anaesthesia on for toxicity associated with occupational expo- 2 the brain: mechanisms and relevance. Nat Rev Neurosci. sure, long-term prospective epidemiological 2016;17:705–717. data are lacking. The National Institute of Occu- 21. Henderson KA, Matthews IP, Adisesh A, et al. Occupational pational Safety and Health recommends a maxi- Dr. Arnolds is an assistant professor in the exposure of midwives to nitrous oxide on delivery suites. Occup Envion Med. 2003;60:958–961. mal time-weighted average level of exposure to Department of Anesthesia and Critical Care at 22. Morley B, Paulsen AW, et al. Nitrous oxide for labor analge- nitrous oxide of no more than 25 ppm over an The University of Chicago, Chicago, IL. sia: is it safe for everyone? APSF Newsletter. 2017;32:19–20. 8-hour period. Compared to well-ventilated https://www.apsf.org/article/nitrous-oxide-for-labor-analge- operating rooms where nitrous oxide is most Dr. Scavone is a professor in the Departments of sia-is-it-safe-for-everyone/ Accessed May 5, 2020. commonly delivered through a closed circuit, Anesthesia and Critical Care and Obstetrics and 23. Bobb LE, Farber MK, McGovern C, et al. Does nitrous oxide labor analgesia influence the pattern of neuraxial analgesia nitrous oxide utilization in a labor suite presents Gynecology at The University of Chicago, Chi- usage? An impact study at an academic medical center. J unique challenges. Without scavenging of cago, IL. Clin Anesth. 2016;35:54–57. APSF NEWSLETTER June 2020 PAGE 62

Successful Evidence-Based International Emergency Manual Implementation Strategy by Kyle Sanchez and Jeffrey Huang, MD

It has been suggested that increasing access to resources and decreasing reliance on rote memory are two potential methods to combat medical errors;1 both of which can be achieved through the use of cognitive aids, such as emer- gency manuals (EMs). Operating room (OR) EMs are paper or digital books with a series of current, medically estab- lished guidelines that detail how health care professionals should respond to specific peri- operative critical events.2,3 The use of EMs by health care providers, especially anesthesia professionals, to guide their performance during nonroutine critical events has been shown to reduce errors and maximize produc- tivity.4 It has been demonstrated that health care providers can respond to crises more effi- ciently,4 confidently,5,6 and collaboratively5,6 10-12 with the aid of OR EMs. Additionally, utilizing patients. Since simulation-based medical in simulation trainings because no one orga- 5 EMs reduced the likelihood of failure to adhere education has been shown to be superior to nized them. A two-hour EM simulation instructor to lifesaving processes of care by four times.7 traditional education for teaching other techni- training was given at the Chinese Association of cal skills,10,13,14 the effectiveness of simulation Anesthesiologists annual meeting and was International awareness of the benefits of EM training on EM usage was studied. Participation shown to be successful in allowing participants utilization continues to increase over time,8 but in simulation training events has indeed been to organize their own EM simulation training implementation itself remains a challenge. associated with increased routine use of EMs workshops in their home institutions.17 Some specific challenges for EM implementa- during critical events.4,5,10,15 Additionally, the loca- tion include difficulty building consensus on tion of the simulation training (OR versus simula- FREE BOOKS: content and format of EMs, resistance by health tion center) likely has no impact on a provider’s Another potential barrier of EM implementa- care providers who prefer to rely solely on their propensity to use EMs in future critical events.10 tion is the required resources and cost of dis- own skills and experience, infeasibility of ideal Thus, the implementation of EMs may be facili- tributing EMs in every OR of a hospital or health studies that measure the effect of EMs on clini- tated by participation in simulation competitions care system. Since there is currently a lack of cal outcomes, and lingering concerns about the or other hands-on educational experiences. research on OR EM utilization in China, trans- pitfalls of EM use, such as fixation on an incor- lated versions of EM were distributed free of 9 rect diagnosis. SIMULATION COMPETITION: charge to anesthesiology departments WORKSHOP: Simulation Wars was created in 2017 by the throughout several hospitals in China in 2018. Clinicians who received EMs demonstrated The Anesthesia Patient Safety Foundation Zhongshan City Society of Anesthesiology in higher levels of EM simulation training participa- (APSF) sponsored a workshop in 2015 entitled China as a competition to promote simulation 16 Implementing and Using Emergency Manuals training. Participating hospitals were tion, EM usage during critical events, self-review and Checklists to Improve Patient Safety, instructed to create a video that demonstrates of EMs, and group study of EMs than anesthe- where audience discussion elicited recommen- the application of EMs to an anesthesia-related sia professionals who did not receive free 5 dations such as the development of a strong critical event, with a specific focus on the use of books. While free EM placement alone is likely 9 18 social media presence of EMs, inclusion of EMs crisis resource management skills. During the unable to provoke actual implementation, free in the presurgical timeout, creation of a public competition’s final round, each hospital per- books can enhance the implementation of EMs 5 APSF education packet on EM usage, and use formed an in-person crisis management dem- and actual EM use during critical events, espe- 16 of research to design an EM simple enough to onstration. A 2018 study performed by Huang cially when combined with simulation training be used without training.9 et al. one year after the inaugural competition and other methods to increase implementation. found that EM usage during real critical events SIMULATION TRAINING: increased significantly following a simulation BOOK LOCATION: A lack of sufficient training programs on EMs training competition.15 Currently, there is still no standardized proto- is reported as the single greatest barrier to EM col for EM usage, despite the widespread usage usage,5 and thus choosing an effective method TRAIN THE TRAINER: of EMs, abundant evidence to support the ben- to train providers on the proper use of EMs is With more hospitals adapting simulation train- efit of EMs when used during critical events, and critical. Simulation-based education allows for ing, it is important to ensure that the EM training ongoing national and international efforts to continuous, directed practice that supports the instructors are proficient and able to organize enhance implementation. An obstacle to using development and advancement of knowledge their own workshops, especially given that many EM may be that events in the operating room and clinical skills without risking harm to anesthesia professionals report not participating See “Emergency Manual,” Next Page APSF NEWSLETTER June 2020 PAGE 63

Emergency Manuals Can Come in Book and Electronic Forms

From “Emergency Manual,” Preceding Page based or staff trainings increase familiarity and planned happen too quickly.5 This obstacle may be over- clinical use?. Jt Comm J Qual Patient Saf. 2015;41:212–220. come by developing a concrete set of instruc- 4. Goldhaber-Fiebert SN, Pollock J, Howard SK,et al. Emer- gency manual uses during actual critical events and tions regarding the time-sensitive access, changes in safety culture from the perspective of anesthe- handling, and utilization of EMs in routine daily sia residents: a pilot study. Anesth Analg. 2016;123:641– practice. A standardized protocol would be 649. especially beneficial for health care providers 5. Huang J, Hoang P, Simmons W, Zhang J. Free emergency with minimal exposure to EMs who become manual books improve actual clinical use during crisis in acutely involved in a critical event. The preferred China. Cureus. 2019;11:e4821. location for EM placement during critical events 6. Huang J, Sanchez K, Wu J, Suprun A. Best location and 6 reader role in usage of emergency manuals during critical is the anesthesia station of the OR, which is con- events: experienced emergency manual users’ opinions. gruent with Stanford University EM group’s rec- Cureus. 2019;11: e4505. 2 ommendation. This location should minimize 7. Fowler AJ, Agha RA. In response: simulation-based trial of the time spent retrieving the EM and, thus, facili- surgical-crisis checklists. Ann Med Surg. 2013;2:31. tate the development of a standardized protocol 8. Simmons W, Huang J. Operating room emergency manuals that allows all providers to quickly and efficiently improve patient safety: a systemic review. Cureus. use an EM in a critical situation. 2019;1:e4888. 10.7759/cureus.4888 9. Morell RC, Cooper JB. APSF sponsors workshop on imple- menting emergency manuals. APSF Newsletter. THE READER’S ROLE: ance with the use of EMs and other cognitive 2016;30:68–71. https://www.apsf.org/article/apsf-sponsors- 19 The preferred reader of EMs during critical aids is also likely unaffected by format. workshop-on-implementing-emergency-manuals/. Accessed October 7, 2019. events is the most experienced health care pro- In conclusion, the use of simulation training fessional,6 which suggests that the leading team 10. Huang J, Wu J, Dai C, et al. Use of emergency manuals was among the first methods shown to facilitate during actual critical events in China: a multi-institutional member should assume the reader role. The dis- the implementation and usage of EMs.4,5,10,15,16 tinction between the reader and leader is critical study. Simul Healthc. 2018;4:253–260. Providing formal EM simulation instructor train- because the reader of EMs temporarily assumes 11. Kneebone R. Simulation in surgical training: educational ing may nurture the growth and effectiveness issues and practical implications. Med Educ. 2003;37:267– a leader-like role with no actual responsibility for of EM simulation programs.17 Free distribution 277. the clinical outcome. By assigning the reader of EMs may further enhance implementation.5 12. Ericsson KA. Deliberate practice and the acquisition and role to the most experienced anesthesia profes- A universal, standardized protocol for EM maintenance of expert performance in medicine and sional, any effect of EM usage on clinical out- related domains. Acad Med. 2004;79:S70–581. usage, which specifies parameters such as come—whether positive or negative—will be 13. McGaghie WC, Issenberg SB, Cohen ER, et al. Does simula- location of placement and reader role,6 is criti- ascribed to the reader. More research is needed tion-based medical education with deliberate practice yield to determine whether the preferred location and cal to support the development and implemen- better results than traditional clinical education? A meta tation of EMs worldwide. analytic comparative review of the evidence. Acad Med. reader of EMs have a significant influence on 2011;86:706–711. clinical outcomes. Moreover, other parameters Kyle Sanchez is a fourth-year medical student 14. Daniels K, Arafeh J, Clark A, et al. Prospective randomized related to EM usage should be identified, at the University of Central Florida College of trial of simulation versus didactic teaching for obstetrical explored, and standardized to gain a more com- Medicine in Orlando, FL. emergencies. Simul Healthc. 2010;5:40–45. prehensive picture. We propose that perhaps 15. Huang J, Parus A, Wu J, Zhang C. Simulation competition Dr. Jeffrey Huang is program director of the HCA the next step toward increasing EM implementa- enhances emergency manual uses during actual critical Healthcare/USF Morsani College of Medicine events. Cureus. 2018;10:e3188. 10.7759/cureus.3188 tion is the development of a standardized proto- col for EM usage. GME Anesthesiology Residency at Oak Hill Hos- 16. Zhang C, Zeng W, Rao Z, et al. Assessment of operating pital in Brooksville, FL, professor at the USF Mor- room emergency manual simulation training. [Article in Chi- sani College of Medicine and professor at the nese]. Perioperative Safety and Quality Assurance. PAPER VERSUS ELECTRONIC EMS: 2017;5:260-262. University of Central Florida College of Medi- Determining the most effective format for 17. Huang J. Successful implementation of a two-hour emer- EMs is critical in creating a standardized proto- cine. He serves on the APSF Committee on Edu- gency manual (EM) simulation instructor training course for col for use. There are several potential advan- cation and Training. anesthesia professionals in China. APSF Newsletter. Oct 2018;33:60–61. https://www.apsf.org/article/successful- tages and disadvantages to the use of hard copy The authors have no conflicts of interest. implementation-of-a-two-hour-emergency-manual-em- versus digital EMs. Advantages to hard-copy simulation-instructor-training-course-for-anesthesia-profes- books include familiarity among all providers, sionals-in-china/ Accessed May 5, 2020. REFERENCES: independence from electronic platforms or 18. Neily J, DeRosier JM, Mills PD, et al. Awareness and use of Wi-Fi, and simple modification by replacing or 1. Leape LL. Error in medicine. JAMA. 1994;272:1851–1857. a cognitive aid for anesthesiology. Jt Comm J Qual Patient adding pages. However, some disadvantages 2 Goldhaber-Fiebert SN, Howard SK. Implementing emer- Saf. 2007;33:502-511. gency manuals: can cognitive aids help translate best prac- of paper copies include the requirement to take 19. Watkins SC, Anders S, Clebone A et al. Mode of information tices for patient care during acute events. Anesth Analg. delivery does not effect anesthesia trainee performance up OR space and their tendency to get mis- 2013;117:1149–1161. during simulated perioperative pediatric critical events: a 19 placed. On the contrary, electronic EMs may 3. Goldhaber-Fiebert SN, Lei V, Nandagopal K, Bereknyei S. trial of paper versus electronic cognitive aids. Simul facilitate user-EM interaction, allow a more Emergency manual implementation: can brief simulation- Healthc. 2016;11:385–393. patient-specific response via input of patient data, and enable decision-making based on 19 APSF accepts stock donations. We work with our investment firm to elapsed time. Disadvantages of electronic Did you take care of the details. You will need the following information to EMs include difficulty with navigation or manip- know? give to your investment advisor/broker dealer. Please let us know of ulation of the application, limited display size, your generosity by notifying Stacey Maxwell at [email protected] so and the obvious risk of technological failures. that we may properly acknowledge your contribution. Despite the proposed advantages and disad- vantages of these formats, the mode of delivery Firm: BNY Mellon/Pershing Account Name: Anesthesia Patient Safety Foundation of EMs—whether paper versus electronic— DTC #: 8420 Account #: UDR900084 likely does not affect clinician performance or clinical outcome.19 Moreover, clinician compli- APSF NEWSLETTER June 2020 PAGE 64

Ketamine: A Review of an Established Yet Often Underappreciated Medication by Jason Kung, MD; Robert C. Meisner, MD; Sheri Berg, MD; and Dan B. Ellis, MD

THE ORIGIN OF KETAMINE Table 1. Potential Benefits and Side dose. Adverse respiratory effects such as Since its synthesis in a Detroit laboratory Effects of Ketamine increased airway secretions may be mitigated nearly six decades ago, ketamine has proven to with the use of anti-sialogogues. Benefits be a complex medication with unusual proper- There are distinct electroencephalogram ties, heterogeneous, interconnected mecha- Maintenance of respiratory drive (EEG) patterns associated with escalating doses nisms, and diverse, sometimes contested, Minimal cardiovascular depression of ketamine as patients develop a gamma burst clinical uses. pattern (gamma oscillations interrupted by Attenuation of perioperative opiate induced Ketamine’s story begins in 1956 when scien- hyperalgesia slow-delta oscillations), followed by a stable tists identified a new class of anesthetic medi- beta/gamma pattern.8 This EEG progression fol- 1 Adjunctive treatment of acute/chronic pain lows closely with a transition into the ketamine- cations called cyclohexaylamines. The first of syndromes this class of medications was called phencycli- induced unconscious state. Thus, because dine (PCP). In 1962, a new compound was dis- Antisuicidal and antidepressive properties there is no isoelectric EEG state associated with covered (CI-581) that possessed all of the Side Effects ketamine, titrating anesthesitic depth to this pat- tern is not recommended. positive qualities of PCP without major negative Increased airway secretions; minimal airway side effects such as severe excitation and pro- reflex attenuation Several historical papers have reported that found psychosis.2 This new medication would Elevated heart rate, blood pressure, and SVR; ketamine increases intracranial pressure eventually be called ketamine. In its initial study, myocardial ischemia in pateints with severe (ICP).9,10 It was postulated that increases in cere- several subjects who received ketamine CAD bral blood flow (CBF) and cerebral oxygen con- described feeling as though they had “no arms Hallucinations, confusion, vivid dreams, sumption led to this increase. Therefore, classic or legs.” Others felt “like they were dead” and delirium teaching was to avoid ketamine in neurological experienced vivid hallucinations. These Prolonged duration in patients with liver procedures. However, several of these studies descriptions led researchers to coin the term, dysfunction allowed patients to breath spontaneously fol- “ anesthesia”.2,3 lowing an induction dose of ketamine, which Double vision, blurry vision may have falsly elevated the ICP due to hyper- BASIC SCIENCE SVR, systemic vascular resistance; CAD, coronary carbia induced vasodilation.11 There have been artery disease Ketamine’s antagonism of the NMDA recep- many recent challenges to this dogma. Current tor is believed to be primarily responsible for research suggests that when used in mechani- its amnestic, anesthetic, and dissociative (Table 1). Increases in blood pressure, heart cally ventilated patients, in conjunction with 4 effects. NMDA receptor blockade has been rate, contractility, and systemic vascular resis- other medications, there is no increase 5 shown to block memory formation in rodents. tance led to the initial description of a sympa- in ICP.12–14 Data for the effect of sub-anesthetic 2 In addition, spinal NMDA receptors are inti- thomimetic effect of ketamine. It is now known ketamine on ICP is lacking, but when given at mately involved in central sensitization and that this observed increase in sympathetic tone this lower, nonsedating dose, the effects on ICP therefore, repeated agonism may lead to is secondary to adrenal catecholamine release are likely to be minimal. hyperalgesia. Activity with NO synthase, triggered by ketamine. Interestingly enough, GABA, and acetylcholine may also contribute ketamine in isolation has a direct negative ino- CURRENT USE IN ANESTHESIOLOGY to the unique and complex actions and side tropic effect which is usually muted by this sym- After ketamine was approved by the Food effects seen with ketamine.6 pathetic surge. Caution should be used when and Drug Administration in 1970, its first major widespread use was as a battlefield anes- Metabolism of ketamine primarily occurs in inducing patients with high sympathetic tone thetic during the Vietnam war.3 In 1985, the the liver where ketamine is converted into nor- (i.e., trauma patients) with ketamine as the car- World Health Organization labeled ketamine ketamine, an active metabolite which also has dio-depressive effects of ketamine may over- an “Essential Medicine,” and it is now thought potent anesthetic properties. In addition to the whelm potential catecholamine release by to be the most commonly used anesthetic in actions of , the lipophilicity of ket- already-stressed adrenal glands. Prudence the world.15 amine may be responsible for ketamine’s pro- should also be exercised in administering ket- longed distributive half-life of 10–15 minutes amine to patients with severe coronary artery In acute care settings such as the intensive following a standard intravenous induction disease, as myocardial oxygen demand is dis- care unit or emergency room, procedural seda- dose of 1 to 2 mg/kg. Unlike other induction proportionately greater than increased oxygen tion with ketamine has been used safely for medications, patients who receive large doses delivery from ketamine administration. decades.16 Its use intraoperatively has seen a of ketamine may develop nystagmus, pupillary Ketamine is one of the few intravenous anes- renewed interest with the rise of the opioid epi- dilation, and their eyes may not close despite thetics that has minimal effects on respiratory demic. Ketamine, when given in sub-anesthetic doses, may reduce opiate tolerance and reaching general anesthetic levels of the medi- patterns. Furthermore, its bronchodilatory decrease opiate-induced hyperalgesia follow- cation. Table 1 summarizes some of the effects may be beneficial specifically in asth- ing surgery.17 When given to patients with common benefits and side effects of ketamine. matic patients.7 The paucity of large random- chronic pain undergoing back surgery, ket- The physiological and psychotropic effects ized control trials along with heterogenous and amine has been shown to reduce pain scores associated with ketamine have been well unreported dosing regimens makes it difficult described following the first human studies to determine an optimum bronchodilatory See “Ketamine,” Next Page APSF NEWSLETTER June 2020 PAGE 65

Safety Considerations For the Use of Ketamine

From “Ketamine,” Preceding Page Table 2. Administration Suggestions30,35,36 and opiate consumption at various time points Route Dosing range postoperatively.18 It may even be beneficial in opiate-naïve patients undergoing procedures Anesthetic induction 1–2 mg/kg with expected painful postoperative courses.19 Loading dose (for sedation and analgesia) 0.1–0.5 mg/kg given over 60 seconds to avoid Table 2 summarizes some commonly used respiratory depression and sympathetic response dosing ranges of ketamine. Bolus/supplemental dose 0.1–0.5 mg/kg as needed Ketamine’s use in neuraxial anesthesia has Sedation/anagelsia (for intubated patients) 5–30 mcg/kg/min been controversial due to the potential for neu- Analgesia (for nonintubated patients) 1–5 mcg/kg/min rotoxicity from preservatives and direct neuro- Treatment resistant depression 0.5 mg/kg over 40 minutes nal cell apoptosis.20 However, both etiologies have only been seen in select animal Table 3. Indications/Contraindications models,21,22 and later studies have not demon- Elevated intra-ocular pressure (IOP) is a com- monly listed contraindication based on early Indications strated clinically relevent neurotoxicity in 28 23 studies, but recent evidence suggests mini- humans. This has led to several studies exam- Analgesia mal fluctuations of IOP.29 The mechanism is ining ketamine’s role in blocking the develop- thought to be due to changes in extraocular • Acute post operative pain ment of post-amputation stump pain24 and muscle tone.28 reduction of post-thoracotomy pain.25 • Chronic pain Given intra-operatively, standard American Acute or chronic pain exacerbations Ketamine is used often by acute pain ser- Society of Anesthesiologists (ASA) monitoring vices to treat postoperative pain not relieved Sedation (mechanical ventilation) should be applied whether ketamine is used as with standard opioid patient-controlled anal- Procedural sedation the sole anesthetic or as an analgesic adjunct. gesia (PCA) regimens. Nonsurgical patients Sub-anesthetic dosing of ketamine still carries Rapid sequence intubation presenting with acute or chronic pain exacerba- risk of airway compromise, cardiovascular per- tions such as vaso-occlusive crises from sickle Treatment-resistant depression turbances, and psychomimetic events. In acute cell disease may also benefit from ketamine.26 Contraindications care settings, blood pressure, electrocardio- Dosing is generally lower with infusions less gram, and pulse oximetry should be available. Psychosis than 0.3 mg/kg/hr, with or without a bolus. The According to The Consensus Guidelines on Active addition of ketamine infusions can reduce The Use of Intravenous Ketamine for Chronic opioid consumption and enhance the transition Severe liver dysfunction Pain from the American Society of Regional from PCA to oral opioids. There is even evi- Significant coronary disease Anesthesia and Pain Medicine (ASRA), the Amer- dence to suggest ketamine-containing PCA ican Academy of Pain Medicine (AMPA, and the Poorly controlled hypertension solutions (1 to 5 mg/bolus) can improve pain American Society of Anesthesiologists (ASA),30 control and reduce opioid consumption.27 supervising practitioners should be Advanced than at sub-anesthetic doses. In this regard, it SAFETY CONSIDERATIONS Cardiovascular Life Support (ACLS) certified and resembles other psychiatric medications such Contraindications to ketamine include preg- meet ASA requirements for moderate sedation. as trazadone, a common multimechanism med- nancy, liver dysfunction, significant coronary Individuals who administer ketamine should hold ication that functions as a sedative at doses disease, and psychosis (Table 3). Elevated ICP, at least a registered nursing degree, received below 150 mg but as an at 33 as described previously, does not occur in training in moderate sedation and ketamine doses above 150 mg. pharmacology, and be ACLS certified. sedated patients under controlled ventilation. Ketamine’s antisuicidal and antidepressant KETAMINE AS AN ANTIDEPRESSANT may be due to serum gluta- Ketamine is produced as a mate concentrations following AMPA activation. of and arketamine. In March 2019, In general, clincians at academic centers who scientific and public interest in ketamine administer intravenous ketamine to patients as a erupted with the FDA’s approval of esket- treatment for depression have, until somewhat amine, racemic ketamine’s positive enantio- recently, gravitated toward a dosing regimen of 34 mer, as a first-in-class antidepressant 0.5 mg/kg over 40 minutes (Table 2). This ten- medication for the management of treatment- dency reflects the preponderance of research at resistant depression.31 this dose, which corresponds to a serum con- centration of approximately 2000–3000 ng/mL. Ketamine demonstrates robust antisuicidal Treatments are typically administered 1 to 3 times and antidepressant properties.32 But as an anti- per week. However, ketamine protocols are not depressant, it may exert categorically different widely shared, and a variety of different dosing effects at different serum concentrations, and regimens exist in various centers, with both its effects may not follow standard dose- research and experience in practice suggesting Two doses of intravenous ketamine, 50mg/ml and response curves. At doses well above full 10mg/ml. Source: Wikipedia. https://creativecommons. the utility of cautiously up-titrating doses. org/share-your-work/licensing-considerations/compat- induction anesthetic doses, ketamine’s antide- ible-licenses pressant effect does not appear to be greater See “Ketamine,” Next Page APSF NEWSLETTER June 2020 PAGE 66

Ketamine May Be Used for Treatment Resistant Depression

From “Ketamine,” Preceding Page Similar to anesthesia society guidelines,30,36 the American Psychiatric Association recom- mends that providers administering ketamine in outpatient settings should be ACLS certi- fied.34 Ketamine’s low likelihood of producing respiratory suppression when used at low doses has contributed to its perception as a relatively “safe” medication at low doses. While the sympathomimetic effects (elevated heart rate and blood pressure) are often seen with anesthesia induction doses, these changes are uncommon when sub-anesthetic doses are administered.35 Monitoring during sedation, at a minimum, should include continuous pulse oximetry and blood pressure checks every ten minutes.35 Likewise, when used in the context 20. Schmid R, Katz J. Neural toxicity of ketamine and other Drs. Kung, Berg, and Ellis have no conflicts of interest. NMDA antagonists. Pain. 2000;88:312. of active suicidal ideation or severe depression, Dr. Meisner has served on advisory boards for 21. Borgbjerg FM, Svennson BA, Frigast C, Gordh T Jr., Histo- the psychiatric effects, both short and long- Janssen Pharmaceutical. pathology after repeated intrathecal injections of preserva- tive-free ketamine in the rabbit: a light and electron term, must be followed and managed to ensure microscopic examination. Anesth Analg. 1994;79:105–111. 34 patient safety. Prior to treatment, patients are REFERENCES 22. Olney JW, Labruyere J, Price MT. Pathological changes interviewed to assess their baseline symptoms 1. Maddox VH, Godefroi EF, Parcell RF. The synthesis of phen- induced in cerebrocortical neurons by and cyclidine and other 1-. J Med Chem. related . Science. 1989;244:1360–1362. and response to treatment. After the infusion is 1965;8:230–235. 23. Subramaniam K, Subramaniam B, Steinbrook RA. Ketamine complete, patients typically recover for 30 min- 2. Domino EF, Chodoff P, Corssen G. Pharmacologic effects of as adjuvant analgesic to opioids: a quantitative and qualita- CI-581, a new dissociative anesthetic, in man. Clin Pharma- tive systematic review. Anesth Analg. 2004;99:482–495. utes to 2 hours before they are discharged with col Ther. 1965;6:279–291. 24. Wilson JA, Nimmo AF, Fleetwood-Walker SM, et al. A ran- an escort. It should be noted that these guide- 3. Mion G. History of anaesthesia. Clin Pharmacol Ther. 2017;34: 571–575. domised double blind trial of the effect of pre-emptive epi- lines are specific to our practice and other insti- dural ketamine on persistent pain after lower limb 4. Persson J. Wherefore ketamine? Curr Opin Anaesthesiol. amputation. Pain. 2008;135:108–118. tutions are likely to have different monitoring 2010;23:455–460. 25. Feltracco P, Barbieri S, Rizzi S, et al. Perioperative analgesic and treatment pathways. Further evidence- 5. Mathews MJ, Mead RN, Galizio, M. Effects of N-Methyl-D- efficacy and plasma concentrations of s( )-ketamine in con- aspartate (NMDA) antagonists ketamine, , based recommendations are needed before tinuous epidural infusion during thoracic surgery. Anesth and phencyclidine on the odor span test of working Analg. 2013;116:1371–1375. memory in rats. Exp Clin Psychopharmacol. 2018;26:6–17. widespread adoption of one set of guidelines. 26. Puri L, Morgan KJ, Anghelescu DL. Ketamine and lidocaine 6. Kohrs R, Durieux ME. Ketamine. Anesth Analg. 1998;87, infusions decrease opioid consumption during vaso-occlu- 1186–1193. sive crisis in adolescents with sickle cell disease.Curr Opin CONCLUSION 7. Agrawal A, Goyal S. Ketamine in status asthmaticus: a Support Palliat Care. 2019;13:402–407. review. Indian J Crit Care Med. 2013;17:154–161. Ketamine is an old drug that is experiencing 27. Wang L, Johnston B, Kaushal A, et al. Ketamine added to 8. Akeju O, Song AH, Hamilos AE, et al. Electroencephalo- morphine or hydromorphone patient-controlled analgesia a new emergence of interest among clinicians gram signatures of ketamine anesthesia-induced uncon- for acute postoperative pain in adults: a systematic review in perioperative medicine and depression man- sciousness. Clin Neurophysiol. 2016;127: 2414–2422. and meta-analysis of randomized trials. Can J Anaesth. 9. Gardner AE, Dannemiller FJ, Dean D. Intracranial cerebro- agement. With progressively more patients suf- 2016;63:311–325. spinal fluid pressure in man during ketamine anesthesia. 28. Yoshikawa K, Murai Y. The effect of ketamine on intraocular fering from chronic pain who require pain Anesth Analg. 1972;51:741–745. pressure in children. Anesth Analg. 1971;50:199–202. 10. Gardner AE, Olson BE, Lichtiger M. Cerebrospinal-fluid management without opioids, and with evolv- pressure during dissociative anesthesia with ketamine. 29. Drayna PC, Estrada C, Wang W, et al. Ketamine sedation is Anesthesiology. 1971;35:226–228. not associated with clinically meaningful elevation of intra- ing utility at minute doses in the treatment of ocular pressure. Am J Emerg Med. 2012;30:1215–1218. 11. Wang X, Ding X, Tong Y, et al. Ketamine does not increase depression and potentially other psychiatric intracranial pressure compared with opioids: meta-analysis 30. Cohen SP, Bhatia A, Buvanendran A, et al. Consensus of randomized controlled trials. J Anesth. 2014;28:821–827. guidelines on the use of intravenous ketamine infusions for disorders, this old drug now has further applica- chronic pain from the American Society of Regional Anes- tions for patient care. However, further investi- 12. Chang LC, Raty SR, Ortiz J, et al. The emerging use of ket- thesia and Pain Medicine, the American Academy of Pain amine for anesthesia and sedation in traumatic brain inju- Medicine, and the American Society of Anesthesiologists. gation is forthcoming as to the appropriate ries. CNS Neurosci Ther. 2013;19:390–395. Reg Anesth Pain Med. 2018;43:521–546. 13. Zeiler FA, Teitelbaum J, West M, et al. The ketamine effect monitoring for administration of this drug in on ICP in traumatic brain injury. Neurocrit Care. 2014;21: 31. Kim J, Farchione T, Potter A, et al. Esketamine for treatment- 163–173. resistant depression­—first FDA-approved antidepressant in a postoperative and outpatient settings. new class. NEJM. 2019;381:1–4. 14. Zeiler FA, Teitelbaum J, West M, Gillman LM. The ketamine Dr. Kung is a resident in Anesthesiology at Mas- effect on intracranial pressure in nontraumatic neurological 32. Ionescu DF, Swee MB, Pavone KJ, et al. Rapid and sustained illness. J Crit Care. 2014;29:1096–1106. reductions in current suicidal ideation following repeated sachusetts General Hospital, Boston, MA. doses of intravenous ketamine secondary analysis of an 15. Fact file on ketamine. (2016, March). Retrieved from https:// open label study. J Clin Psychiatry. 2016;77:e7-19-25. www.who.int/medicines/news/20160309_FactFile_Ket- Dr. Meisner is the medical director of the Ket- amine.pdf?ua=1. 33. Stahl SM. Mechanism of action of trazodone: a multifunc- tional drug. CNS Spectr. 2009;14:536–546. amine Service at McClean Hospital in Belmont, 16. Sheikh S, Phyllis H. The expanding role of ketamine in the emergency department. Drugs. 2018;78:727–735. 34. Sanacora G, Frye MA, Mcdonald W, et al. A Consensus MA and assistant in psychiatry at the Massa- 17. Nielsen RV, Fomsgaard JS, Siegel H, et al. Intraoperative Statement on the Use of Ketamine in the Treatment of chusetts General Hospital, Boston, MA. ketamine reduces immediate postoperative opioid con- Mood Disorders. JAMA Psychiatry. 2017;74:399. sumption after spinal fusion surgery in chronic pain patients 35. Riva-Posse P, Reiff CM, Edwards JA, et al. Blood pressure Dr. Berg is an assistant professor of Anesthesi- with opioid dependency. Pain. 2017;158:463–470. safety of subanesthetic ketamine for depression: a report 18. Loftus RW, Yeager MP, Clark JA, et al. Intraoperative ket- on 684 infusions. J Affect Disord. 2018;236:291–297. ology at Massachusetts General Hospital, amine reduces perioperative opiate consumption in opiate- 36. Schwenk ES, Viscusi ER, Buvanendran A, et al. Consensus Boston, MA. dependent patients with chronic back pain undergoing guidelines on the use of intravenous ketamine infusions for back surgery. Anesthesiology. 2010;113:639–646. acute pain management from the American Society of Dr. Ellis is an instructor of Anesthesiology at 19. Laskowski K, Stirling A, McKay WP, Lim HJ. A systematic Regional Anesthesia and Pain Medicine, the American review of intravenous ketamine for postoperative analge- Academy of Pain Medicine, and the American Society of Massachusetts General Hospital, Boston, MA. sia. Can J Anaesth. 2011;58:911–923. Anesthesiologists. Reg Anesth Pain Med. 2018:43:456-466. 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ALSO IN THIS ISSUE: An Update on the Perioperative Considerations for COVID-19 Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)

COVID-19 Pandemic—Decontamination of Respirators and Masks for the General Public, Health Care Workers, and Hospital Environments

Postoperative Recurarization After Sugammadex Administration Due to the Lack of Appropriate Neuromuscular Monitoring: The Japanese Experience

Effective Leadership and Patient Safety Culture

Educating the Next Generation: A Curriculum for Providing Safe Anesthesia in Office-Based Surgery