Identification of Patients at High Risk for Opioid-Induced Respiratory Depression

Identification of Patients at High Risk For Opioid-induced Respiratory Depression

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Carla R. Jungquist, PhD, ANP-BC, FAAN Associate Professor University at Buffalo School of Nursing

Thank you to our sponsors

This webinar is sponsored by the American Society for Pain Management Nursing and Medtronic, Inc. ‘- Conflicts of Interest: Dr. Jungquist has received salary support from Medtronic, Inc. for her role as University at Buffalo site primary investigator for their PRODIGY study. Dr. Jungquist was lead author for the 2019 Revisions to the ASPMN Monitoring for Advancing Sedation and Respiratory Depression Clinical Practice Guidelines for the Hospitalized Patient. 2

Objectives

• Review significance of the problem • Introduce recommendations for stratifying patient risk ‘- • PRODIGY study • Recommendations for integration into practice according to the ASPMN Monitoring Guidelines

3 Respiratory Compromise • describes a deterioration in respiratory function in which there is a high likelihood of decompensation into respiratory failure or death ‘- **Looking to improve patient safety by early detection of patient deterioration by best practices for detecting respiratory compromise.

*Provided by Covidien

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1. Linde-Zwirble WL, Bloom JD, Mecca RS, Hansell DM. Postoperative pulmonary complications in adult elective surgery patients in the US: severity, outcome and resources use. Crit Care Med. 2010;14: P210. 2. Agarwal SJ, Erslon MG, Bloom JD. Projected incidence and cost of respiratory failure, insufficiency and 1. Linde-Zwirblearrest WL, in Bloom Medicare JD, Mecca population, RS, Hansell 2019.DM. Postoperative Abstract pulmonary presented complications at Academy in adult Health elective Congress surgery patients, June in the 2011. US: 3. Wier severity, outcomeLM, Henke and resources R, Friedman use. Crit Care B. DiagnosticMed. 2010;14: GroupsP210. 2. Agarwal with Rapidly SJ, Erslon Increasing MG, Bloom JD. Costs, Projected by incidencePayer, and 2001 cost -2007. of respiratory Healthcarefailure, insufficiency Cost and and arrest Utilization in Medicare Project. population, Agency 2019. Abstract for Healthcare presented at Academy Research Health and Congress Quality., June Statistical 2011. 3. Brief #91. Wier LM, Henke R, Friedman B. Diagnostic Groups with Rapidly Increasing Costs, by Payer, 2001 -2007. Healthcare Cost and Utilization Project. AgencyJune for 2010. Healthcare Available Research at: and http://ww.hcupus.ahrq.gov/reports/statbriefs/sb91.pd Quality. Statistical Brief #91. June 2010. Available at: f 4. Kelley SD, Agarwal S, Parikh N, Erslon M, Morris P. Respiratory insufficiency, arrest and failure among medical patients5

Incidence • American Heart Association Get with the Guidelines – Resuscitation Data • 320 hospitals • 44,551 acute respiratory events in U.S. hospitals‘- in 2012 • 86% mortality in those that progressed to cardiac arrest - characteristics associated with mortality was: • agonal breathing • septicemia • hypotension

Resuscitation. 105:123-9, 2016 08. 6 Significance of OIRD Up to 4.2% of all hospitalized patients administered opioids for acute pain will experience some type of opioid related adverse events Postsurgical patients experiencing opioid-related adverse drug events have: 55% longer hospital stays ‘- 47% higher costs associated with their care 36% increased risk of 30-day readmission 3.4 times higher risk of inpatient mortality compared to those with no opioid-related adverse drug events Opioid-related sentinel events cost the healthcare system $2.5 million per claim on average as well as contribute to nurse burnout (Davis et al., 2017; Fouladpour et al., 2016; Herzig, Rothberg, Cheung, Ngo, & Marcantonio, 2014; Kessler, Shah, Gruschkus, & Raju, 2013; Rosenfeld et al., 2016) 7

NARCAN

5/6

Respiratory Event: Time since last nursing assessment

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9 Recommendations to address the problem

• American Society of Anesthesiologists Task Force on Acute Pain • American Society of Enhanced Recovery ‘- • American Society for Pain Management Nursing • American Pain Society • Society for Anesthesia and Sleep Medicine • Anesthesia Patient Safety Foundation

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Recommendation 1

The panel recommends that pain management strategies be individualized and aligned with peer-reviewed published evidence-based guidelines and the joint commission current pain standards (strong recommendation,‘- high-level evidence).

12 Recommendation 2

The panel recommends that clinicians recognize that all hospitalized patients receiving systemic (e.g., transdermal, IV, oral) or neuraxial ‘- opioids for acute pain management are at risk of opioid-induced unintended advancing sedation and opioid-induced respiratory depression. Some patients are at high-risk for opioid-induced adverse events (see Table 2) (strong recommendation, high level evidence).

13 Recommendation 3

The panel recommendations that all patients who will receive opioids undergo a comprehensive assessment of level of individual risk prior ‘- to initiation of opioid therapy. Ongoing re-assessment of risk that continues through the trajectory of clinical care is essential (strong recommendation, moderate level evidence).

18 Recommendation 4

The panel recommends that ongoing individualized patient-centric plans of care be based on the patient’s level of risk, which may ‘- change over the course of hospitalization, be developed, revised as needed, and communicated among all members of the patient care team (strong recommendation, moderate level evidence).

Recommendation 5

The panel recommends that clinicians identify patients at high-risk of opioid-induced unintended advancing sedation and opioid-induced respiratory depression by using evidence-based criteria which ‘- includes the use of validated assessment scales/instruments (strong recommendation, high level evidence).

https://www.drugabuse.gov/sites/default/files/files/OpioidRiskTool.pdf (ORT)

https://www.jopan.org/article/S1089-9472(15)00070-2/pdf (MOSS)

PRODIGY Risk Prediction Tool (under review)

STOP-BANG Questionnaire 20

Stratifying Risk

• STOP-BANG questionnaire • Pre-op sleep studies or nocturnal oximetry ‘- study

(Chung et al., 2015; Adams, Butas, & Spurlock, 2015)

21 The PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY – PRODIGY Study

• Objective: Develop a risk stratification score for Opioid induced Respiratory Depression ‘- • Design: Multisite Observational • Measures:

Continuous SpO2 + etCO2 for patients receiving parenteral opioids for acute pain.

Study Design

• Enrolled 1,495 adult patients at 16 sites in US, EU, & Asia • Patients were expected to receive parenteral opioid therapy on the GCF ‘- • Analysis set included 1,335 enrolled patients who: • received opioid therapy on GCF • started continuous monitoring

Measures of OIRD

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24 The PRODIGY study - Definition of an OIRD episode

OIRD episode defined as: RR ≤ 5 breaths for ≥ 3 continuous minutes ‘- SpO2 ≤ 85% for ≥ 3 continuous minutes etCO2 ≤15 or ≥ 60 mmHg for ≥ 3 continuous minutes apnea episode lasting >30 seconds or any respiratory opioid-related adverse event

Independent Clinical Event Committee adjudicated OIRD episodes

Predictor Variables Analysis

46 potential predictors assessed

‘- PRODIGY Risk Score determined using all significant predictors from multivariate risk prediction model

USA Europe Asia Total Significance Participant Characteristics (n=769) (n=254) (n=312) (n=1335) Age (yrs) Rate of RD <60 32.8% 16.5% 11.2% 24.6% <.001 episodes: ≥60 - <70 23.9% 33.9% 39.1% 29.4% 614/1335 ≥70 - <80 13.4% 18.1% 24.0% 16.8% monitored ≥80 3.1% 4.7% 4.2% 3.7% patients = Sex (Male) 37.3% 49.6% 50.3% 42.7% <.001 46% BMI (kg/m2) <20 4.0% 4.0% 11.5%‘- 5.8% <.001 ≥20 - <25 18.6% 35.3% 44.2% 27.7% ≥25 - <30 27.0% 32.9% 30.4% 29.0% ≥30 - <35 19.0% 17.5% 11.2% 16.9% ≥35 31.3% 10.3% 2.6% 20.6% Current Smoker 15.6% 19.3% 9.6% 14.9% .004 Neck circumference 45.8% 24.9% 5.4% 32.7% <.001 (≥17 in M; ≥16 in F) Stop Bang Score Class Low Risk (0-2) 45.4% 53.1% 57.5% 49.6% <.001 Intermediate Risk (3-4) 35.1% 31.3% 36.5% 34.8% High Risk (5-8) 19.6% 15.6% 5.8% 15.6% 27 USA Europe Asia Total Significance Participant Characteristics (n=769) (n=254) (n=312) (n=1335) ASA Physical Status ASA I 0.5% 13.8% 24.0% 8.7% <.001 ASA II 35.8% 59.8% 66.0% 47.6% ASA III 60.2% 26.0% 9.9% 41.6% ASA IV 3.5% 0.4% 0.0% 2.1% Surgery Demographics Surgical Patient 90.1% 100.0% 100.0% 94.3% <.001 Length of Surgery (hr) ‘- <2 37.7% 20.9% 27.9% 32.2% <.001 ≥2 - <4 40.4% 49.2% 38.1% 41.6% ≥4 21.8% 29.9% 34.0% 26.2% Opioid Demographics Opioid Naïve*** 71.7% 88.2% 96.5% 80.6% <.001 Multiple Opioids/ 93.9% 86.6% 98.1% 93.5% <.001 Concurrent CNS/Sedating Medication Number of Distinct Opioids One opioid 9.0% 20.5% 2.6% 9.7% <0.001 Opioid number >1 - <4 58.6% 59.8% 88.8% 65.9% <0.001 Opioid number ≥4 32.4% 19.7% 8.7% 24.4%

***Opioid naïve was defined as no use of any opioids in patient medication history 28

Patients with ≥ 1 RD Patients without Significance OR Predictors episode (n = 614) RD (n = 721) (P value) Age ≥70 - <80 yrs 24.3% 10.4% 4.12 <.001 ≥80 yrs 5.5% 2.1% 4.70 .014 Sex (Male) 53.3% 33.7% 2.24 <.001 BMI ≥20 - <25 30.7% 25.2%‘- 1.31 .029 ≥35 15.0% 25.4% .64 <.001 Chronic Heart Failure 3.9% 1.5% 2.63 .009 Coronary Artery Disease 7.7% 4.7% 1.68 .025 Hypertension 52.3% 40.4% 1.62 <.001 Diabetes - Type II 18.2% 14.1% 1.35 .043 Kidney Failure 5.4% 2.9% 1.89 .025 Asthma 9.0% 14.8% .56 .001 Number of distinct opioids Opioid Naive 84.7% 77.1% 1.64 <.001 Opioid number ≥1 - <4 70.2% 62.3% 1.29 .009 29

PRODIGY Risk Score Distribution

Multivariate Model Predictors Points if Clinical Clinical Characteristic Estimate OR Pr > |t| Characteristic = ‘Yes’ Age (≥60 - <70) 0.8077 2.243 <.001 8 Age (≥70 - <80) 1.2323 3.429 <.001 12 Age (≥80) 1.5647 4.781 <.001 16 Sex (M) 0.7550 2.128 <.001 8 Opioid Naïve 0.2912 1.338 .078 3 Sleep Disorders 0.4755 1.609 .018 5 Chronic Heart Failure 0.7494 2.116 ‘- .067 7 Sum = PRODIGY Score PRODIGY Score Distribution Low Risk Intermediate Risk High Risk P value PRODIGY Score <8 points ≥8 & <15 points ≥15 points % Pts with RD in Risk Category 24% 42% 65% <.001 Sensitivity --- 0.86 0.52 Specificity --- 0.39 0.77

ORIL = 2.34; P<.001 OR (P value) ORHI = 2.6; P<.001 ORHL = 6.07; P<.001 30 PRODIGY Model Accuracy = 0.76

‘- Sensitivity

PRODIGY – Secondary Outcomes

Participants that scored > 8 on the instrument: ‘- • Higher incidence of adverse events

PRODIGY – Secondary Outcomes

Characterize the predictive values of individual parameters:

• end tidal CO2 ‘-

• SpO2 • respiratory rate

• Integrated Pulmonary Index™ algorithm (etCO2, SpO2, RR, and HR)

33 Summary of PRODIGY findings

• RD episodes are common • Clinical relevance of the RD episodes is not known, but in this study the participants who experienced these episodes had longer lengths of stay and more clinically relevant rapid response calls. ‘- • Repetitive exposure to RD episodes may contribute to significant morbidity • Current monitoring standards may not detect these events • PRODIGY risk score: easy to implement tool for prediction of RD episodes • Patients rated as high-risk by the PRODIGY score may benefit from proactive bedside interventions and need continuous cardiorespiratory monitoring

Recommendation 6

The panel recommends that clinicians employ evidence-based pain management that incorporates opioid-sparing and multimodal ‘- analgesia therapies (strong recommendation, high level evidence).

Recommendation 7

The panel recommends that hospital policies and procedures reflect evidence-based and nationally published standards and ensure 1) ‘- effective communication among all members of the patient care team, 2) adequate and safe staffing ratios, and 3) purposeful hourly rounding by nursing staff (strong recommendation, weak to high levels of evidence).

36 Recommendation 8

The panel recommends that the nature, timing, frequency, and intensity of monitoring practices be based on ongoing nursing ‘- assessment and re-assessment of patient’s risks and response to pain therapies. Adaptations to the plan of care are driven by iterative assessments (strong recommendation, moderate level of evidence).

Recommendation 9

The panel recommends evidence-based systematic nursing assessments for opioid-induced unintended advancing sedation and respiratory depression inclusive of 1) level of sedation, 2) respiratory rate and quality, and 3) oxygen saturation prior to initiation of‘- opioid therapy, before administering an opioid dose, and at peak effect of opioid and/or other sedating medication co-administered within the therapeutic window of an opioid. Systematic nursing assessments should not be replaced with continuous electronic monitoring (strong recommendation, moderate level evidence).

Recommendation 10

The panel recommends, that all patients deemed to be at risk for opioid- induced unintended advancing sedation and opioid-induced respiratory depression be evaluated for continuous‘- electronic monitoring (see Table 2); and that the type of electronic monitoring be appropriate to the condition of the patient, presence of supplemental oxygen or positive airway pressure therapy, patient’s response to care, patient comfort and adherence to monitoring device, and the detection capability of the technology (strong recommendation, weak level evidence).

39 Monitoring Devices

Oxygenation

• Pulse Oximetry

Ventilation ‘- • Capnography

• Minute Ventilation

• Pulse Oximetry AND Respiratory Rate

• Transcutaneous Carbon Dioxide

Adverse event ending with Anoxic Brain Injury

Pulse Oximetry Over 36 Hours Pulse Ox

100

90 ‘-

60 1 2 3 4 5 6 7 8 9

Intermittent Oxygen Saturation Checks 41

What happens when we add supplemental O2?

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42 PACU study -- Slashed vertical lines are doses of opioid

Jungquist, C.R., Chandola, V., Spulecki, C., Nguyen, K.V., Crescenzi, P., Tekeste, D. (2019) “Identifying Patients Experiencing Opioid Induced Respiratory Depression during Recovery from Anesthesia: The application of electronic monitoring devices. World View in Evidence Based Nursing, 16 (3) 186-194. http://dx.doi.org/10.1111/wvn.12362

Recommendation 11

The panel recommends the judicious use of naloxone based on patient evidence of life-threatening adverse events (strong ‘- recommendation, moderate level evidence).

Recommendation 12

The panel recommends clinician education on evidence-based and best practices for: 1) determining patient risks for opioid-induced unintended advancing sedation and respiratory depression; 2) best practices on assessing level of sedation and ‘- respiratory status; 3) use of trend monitoring as opposed to threshold monitoring when evaluating indicators for respiratory status; 4) appropriate use of positive airway pressure therapy; 5) early implementation of appropriate interventions when advancing sedation and respiratory depression are imminent: and 6) appropriately educating patients/ family members who want to know how to participate in safety efforts. (strong recommendation, weak level evidence).

45 Recommendation 13 The panel recommends that hospital leadership support the development of practice and administrative policies and procedures that outline the implementation of strategies focusing on: 1) clinician, patient, and family awareness of and strategies to avoid the problem; 2) education of clinicians, patient, and family on risk assessment and adaptation of individualized monitoring ‘- procedures and policies; 3) proper training on the use of electronic monitoring systems with potential use of risk alerts within electronic health record systems. (strong recommendation, moderate level evidence).

The panel recommends the development of evidence-based policies and procedures that support clinicians, patients and family members education about the patient’s use of positive airway pressure devices to treat obstructive sleep apnea and obesity hypoventilation syndrome during hospitalization. (strong recommendation, weak level evidence). 46

Thank You!

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