Rhinologic Practice Special Considerations During COVID-19: Visit Planning, Personal

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1 Rhinologic Practice Special Considerations during COVID-19: Visit Planning, Personal

2 Protective Equipment, Testing, and Environmental Controls

3 Authors: Brittany Emma Howard MD

4 Devyani Lal MD

5 Affiliation: Department of Otolaryngology – Head and Neck Surgery

6 Mayo Clinic Arizona

7 5777 E Mayo Blvd

8 Phoenix, AZ 85054

9 Phone: 480-342-2928

10 Fax: 480-342-2626

11 Corresponding Author: Brittany Emma Howard MD

12 Email: [email protected]

13 Key Words: SARS CoV-2, COVID, COVID-19, rhinology, rhinologic, otolaryngology, personal

14 protective equipment, PPE, aerosol generating procedure, environmental safety, environmental

15 control, testing, visit planning, planning, high risk aerosol, eye protection, respiratory protection,

16 air handling, air changes per hour, oropharyngeal swab

17 Conflicts of Interest: the authors have no conflicts of interest related to this research in the past

18 24 months or upcoming.

19 Author Contribution:

20 Brittany Howard: design, conducting review, analysis, writing

21 Devyani Lal: design, conducting review, analysis, writing

22 Sponsor/Funding: None

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23 Abstract

24 As rhinologists return to practice amidst SARS-CoV-2, special considerations are warranted

25 given the unique features of their subspecialty. Rhinologist manipulation of nasal tissue,

26 proximity, and frequent aerosol generating procedures (AGPs) create high-risk for infection

27 transmission. To mitigate risk, four areas of special consideration are: 1) pre-visit planning for

28 risk stratification/mitigation, 2) appropriate personal protective equipment, 3) pre-procedural

29 testing, and 4) environmental controls. During pre-visit planning, risk factors of the patient and

30 procedures are considered. High-risk AGPs are identified by duration, proximity, manipulation

31 of high-viral load tissue, and use of powered instrumentation. Appropriate personal protective

32 equipment includes selection of both respiratory and eye protection. COVID-19 testing can

33 screen for asymptomatic carriers prior to high-risk procedures; however, alternative testing

34 methods are required in rhinologic patients not appropriate for nasopharyngeal testing due to

35 nasal obstruction or skull base defects. Lastly, AGPs in rhinologic practices require

36 considerations of room air handling and environmental controls.

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38 Introduction

39 The predilection of the SARS CoV-2 (“novel corona virus”) to exist with high viral loads in the

40 nose and nasopharynx creates unique challenges for managing patients with rhinologic

41 conditions during the COVID-19 pandemic. It is now recognized that Otolaryngology-Head

42 Neck surgeons are especially vulnerable to high viral load exposure during rhinologic and

43 endoscopic sinus and skull base procedures.1 Additionally, rhinologic surgeons and their teams

44 are at high risk in office-based settings due to close proximity to patients in smaller while

45 performing nasal endoscopy, nasal debridement and other nasal procedures. Strategies to

46 mitigate these risks have been four-fold (Figure 1). The first is identification of factors resulting

47 in “high-risk” or aerosol generating; the second is to choose appropriate personal protective

48 equipment (PPE) to the entire healthcare team, the third is to test the patients for COVID-19

49 prior to elective visits/procedures, and the fourth is environmental modification of the physical

50 location where examination and procedures are to be performed. Within each of these facets,

51 there are issues that are unique to rhinologic surgeon that need to be thoughtfully considered.

53 Pre-visit Planning

54 Pre-visit planning is essential for risk stratification and mitigation. This begins with office

55 preparation through identification of PPE needs and pathways to secure necessary supplies.

56 Education regarding reuse/extended use of single use PPE and utilization of reusable PPE is

57 essential prior to restarting the office-based practice. Once visits are scheduled, pre-visit

58 planning for individual patients begins with a screening call to the individual to screen for the

59 possibility of an active infection or asymptomatic carriage prior to the day of appointment

60 (signs/symptoms, potential exposures, etc). This call is also used to educate patients for the

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61 modified etiquette and protocols necessary for care during the pandemic including wearing a

62 mask and practicing social distancing at all times while in the clinic. On the day of a clinic visit,

63 consideration can be given clinic check-in screening tools (temperature, pulse-ox, etc.) and

64 obtaining the patient history at via distance communication (telephone or virtual

65 communication).2

67 Identification of High-Risk and Aerosol Generating Procedures

68 Identification of factors creating a “high-risk” procedure is imperative to estimate the potential

69 for high viral load exposure and allow surgeons and their teams to select appropriate levels of

70 respiratory protection. Eye protection is encouraged when examining any rhinology patient.2-3

71 Increased risk is created with: prolonged procedural duration, aerosol generating procedures,

72 proximity to aerosols, manipulation of high-viral load tissue, and use of energy instrumentation

73 (cautery, laser, drill, saws, and ultrasonic technology).1

74 The SARS CoV-2 virus is thought to spread via respiratory droplets and aerosols. Respiratory

75 droplets during normal speech and respiration travel less than 6 feet in the unmasked patient.4

76 Therefore, during examination of the nose, the physician should encourage masking the mouth.

77 Patients should be advised prior to nasal endoscopy and procedures to cover their faces if a

78 sneeze or cough is impending; droplets and aerosols generated during forceful coughing or

79 sneezing can extend to 23 to 27 feet.5-6 The droplet nuclei in aerosols can be inhaled by

80 bystanders directly into the lung as opposed to respiratory droplets. While droplets typically fall

81 to the ground within 30 min (ref), aerosols may linger in the air for up to 3 hours, and remains

82 viable during that time.7

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84 Systematic review of data from the 2003 SARS outbreak for transmission to healthcare workers

85 identified endotracheal intubation as the procedure that had the greatest association with

86 nosocomial infection across multiple studies.8 Extrapolation of this data suggests that high-risk

87 aerosol generating procedures are those events associated with similar or greater duration of

88 exposure and proximity to aerosols from the airway compared to intubation.1 The average time

89 for intubation varies between less than 1 minute to 25 minutes depending on situation (emergent

90 verses planned) and difficulty.9-10 For rhinologists, consideration to the duration of their surgical

91 cases and clinic procedures needs to be considered as they may meet criteria as high-risk AGP

92 due to their duration and the staff proximity to the airway. Physicians should also be cognizant

93 that speech itself is aerosol generating and engage in only essential conversation when in close

94 proximity of an unmasked patient.11 Additionally, sneezing can be induced when examining

95 patients during allergy exacerbations, sinusitis exacerbations, or with any manipulation of the

96 nasal passageways; this can convert any encounter to an aerosol enriched environment and

97 increase the “at-risk” radius beyond 6 feet.5-6

99 The high viral loads present in nasopharyngeal tissue is another risk factor for rhinologists during

100 AGPs. The highest viral loads appear to exist in nasal cavity and nasopharynx.12-13 Under

101 standard conditions, clinic endoscopy manipulating nasal/nasopharyngeal tissue create

102 aerosolized droplets that travel up to 66 cm from the nare.14 The risk of aerosolization during

103 suctioning of the nasal cavity and nasopharynx remains unclear.14-15 While use of nasal atomizer

104 sprays has been discouraged to decrease the risk of aerosolization, adequate anesthetic via

105 alternative means (pledgets, etc.) is very important not only for patient comfort, but to decrease

106 airway irritability that can induce forceful coughing or sneezing during procedures.2

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107

108 Lastly, the powered instrumentation utilized by rhinologists in clinic or operating room settings

109 is known to create aerosol generation. Drills may be the highest risk instruments for aerosol

110 generation and are known to include viable infectious particles that travel the entire room. 14,16-18

111 This aerosol effect is known to also occur with use of ultrasonic instruments.16 Additionally,

112 data confirms that laser and electrocautery energy instruments create an aerosolized plume of

113 viable infectious particles.17,19-22

114

115 Selection of Personal Protective Equipment:

116 Selection of PPE must prioritize the health of the operating team. For all aerosol generating

117 procedures, minimum recommended PPE includes gloves, gown, eye protection (googles verses

118 face shield), and minimum of an N95 respirator. While N95 respirators are recommended for

119 AGPs, achieving a durable correct fit with these respirators is a challenge for many. This may be

120 related to facial habitus, duration of procedure, and need for uncommon positioning and

121 movement of the head on the neck.23-24 Additionally, the tight-seal needed necessitated for N95s

122 with their non-adjustable bands, can cause significant facial trauma and respiratory compromise

123 to healthcare workers over repeated use, or after procedures that last long durations.25-26 For

124 standard airborne precautions, N95 masks are appropriate for respiratory protection. However,

125 for surgeons involved in recurrent or long-duration high-risk aerosol generating procedures,

126 enhanced respiratory protection with filters certified as 99, 100, or HEPA may be appropriate in

127 these circumstances.1, 27-28 Options for enhanced respiratory protection that meet these criteria

128 include: disposable masks rated between N-P 99-100, elastomeric respirators with filters rated

129 between N-P 99-100, powered air-purifying respirator (PAPR), or controlled air-purifying

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130 respirator (CAPR). The American Academy of Otolaryngology – Head and Neck Surgery

131 Guidance for Return to Practice recommends that when treating known COVID-19 infected

132 patients, “maximal available and appropriate PPE should be used during all levels of

133 interaction”.2

134 Eye protection is appropriate during patient interactions.29 Regarding eye protection, there is

135 mixed information current published concerning appropriateness of face shields verses goggles

136 for protection from infectious particles during AGPs. The CDC current recommendations for

137 PPE during the COVID pandemic include both goggles and face shields as acceptable eye

138 protection during standard AGPs.30 However, under their referenced supplementary material for

139 SARS viruses, the CDC also specifically states that fitted goggles need to be worn during AGPs

140 and face shields “should not be worn as a primary form of eye protection”.27 Evidence from the

141 medical literature supports the use of goggles in preference over face shields to adequately

142 protect from aerosols. A cough simulator study showed that face shields were only 23-68%

143 effective at blocking aerosols and their efficacy decreased with exposure time.31 Evidence from

144 2003 SARS additionally showed the use of goggles was an independent factor decreasing the

145 risk of nosocomial infection. Thus, the American Academy of Ophthalmology recommends that

146 goggles are preferred over face shields for ocular protection during AGPs.3,32 A preference for

147 occlusive eyewear is further supported by the American Academy of Otolaryngology – Head and

148 Neck Surgery Guidance for Return to Practice.2

149

150 COVID-19 Testing

151 Current guidelines recommend COVID-19 testing prior to performing non-emergent high-risk

152 aerosol generating surgery and consideration for testing before aerosol generating procedures;

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153 recognizing there are limitations on availability of testing in certain areas.33 The decision to

154 perform testing prior to in-clinic procedures needs to be guided by testing availability and

155 frequency of COVID-19 disease in the community. Where available, pre-visit testing can be

156 employed to screen patients for asymptomatic carriage of the SARS Cov2 virus, especially in

157 geographical areas with high prevalence. It is important to be familiar with the sensitivity and

158 specificity of the test used. Results of testing can help defer non-essential procedures, as well as

159 help cohort patients for examination and management in suitable environmental settings. If

160 testing is not available or results cannot be obtained in an actionable time period, full COVID-19

161 precautions should be used for all patients undergoing AGPs in regions experiencing high

162 incidence of disease.34

163 Pre-procedure testing for rhinologic patients has also not been adequately studied. Standard

164 testing is performed trans-nasally to sample the nasopharynx by means of a swab. However,

165 rhinology patients haves special considerations that make nasopharyngeal testing difficult,

166 inaccurate, or dangerous. As a result, the method of testing for patients in a rhinology practice

167 deserves discussion and consideration of possible alternative testing methods.

168 Many rhinology patients have anatomical considerations that may make them poor candidates for

169 nasopharyngeal sampling including a severely deviated septum, obstructing nasal tumor, and

170 obstructing nasal mass (such as postoperative dressing/splints). Further, patients undergoing

171 sinus surgery may have pus and/or polyps within the nasal passageway that may impact the

172 sampling, sensitivity, and negative predictive value of the test. Additionally, postoperative

173 patients who have had recent skull base surgery, blind nasopharyngeal testing is inappropriate

174 and may risk significant morbidity from skull base violation. In this select patient group, testing

175 alternatives to nasopharyngeal sampling needs to be considered. The preference for

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176 nasopharyngeal sampling is based on evidence that viral loads are higher in the nasopharynx than

177 the oropharynx, and experience out of China showing higher rates of disease detection in

178 nasopharyngeal swabs compared to oropharyngeal swabs.12, 35-36 However, there is a growing

179 body of literature that alternative sampling methods may be equivalent alternatives for COVID

180 detection.

181 One option is sputum samples rather than nasopharyngeal samples. A study of 213 COVID

182 positive patients by Yang et al31 commonly cited supporting nasopharyngeal swabs, actually

183 shows that sputum had a higher rate of disease detection (74.4-88.9% sensitivity) compared to

184 nasopharyngeal swabs (53.6-73.3% sensitivity). The high viral load of sputum samples has been

185 supported in additional studies and suggested as an equivalent or superior testing option.37-39

186 However, not all patients undergoing testing are capable of producing a sputum sample (<30%)

187 limiting its broad application.40

188 Alternatively, an oropharyngeal sample is an option in patients that cannot have a

189 nasopharyngeal sample taken due to obstruction, contamination, or safety concerns. Initially

190 discounted as inaccurate, further data suggests oropharyngeal sample testing may be a reasonable

191 alternative. The presence of high viral load in the oropharynx tissue has been demonstrated.13,39

192 Smaller studies than those supporting nasopharyngeal swabs have also shown equivalent or

193 improved detection rates using oropharyngeal swabs and/or oropharyngeal throat washings.37,41-

194 42 These findings are supported in patient collected samples as well.43 As a result, oropharyngeal

195 sampling is recognized by the CDC as an acceptable alternative site to nasopharyngeal sampling

196 for COVID-19 testing.44 Given these findings, and potential inability to perform an accurate

197 and/or safe nasopharyngeal swab in rhinology patients, consideration to creating a separate

198 testing workflow for this patient population should be considered.

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199

200 Environmental Infection Control

201 In additional to provider and patient considers, the safety of the physical space must be

202 considered when treating rhinology patients. AGPs are known to create aerosol droplet nuclei

203 that can travel 23 – 27 feet and remain viable while airborne for up to 3 hrs.4-5, 7 The CDC

204 recommends that exam rooms remain vacant following a patient interaction dependent on the

205 room characteristics, level of risk, duration of time in the room, and performance of AGP such

206 that “sufficient time has elapsed for enough air changes to remove potentially infectious

207 particles”.30, 34 If universal precautions are extended to all patients undergoing AGPs, special

208 considerations regarding air handling and room down time prior to cleaning following an AGP

209 are needed. The CDC has detailed the tables regarding air changes per hour and relative time for

210 clearance of 99% and 99.9% of airborne contaminants (ex: for room with 6 air changes per hour,

211 it takes 46 minutes for 99% of airborne contaminants to be removed).45

212 Due to the frequency of AGPs in rhinologic clinical practices and need for room turnover,

213 options to improve both the safety of the facility and efficiency of the clinic need to be

214 considered. First, the current air handling of all clinical rooms should be reviewed with the

215 building environmental services to educate the practice on room air handling. If possible, the air

216 changes per hour should be increased to improve the efficiency of air contaminant removal, and

217 therefore decrease the time a room is closed following an AGP (for example, at 12 air changes

218 per hour 99% of airborne contaminants are removed in 23 minutes). Second, the practice can

219 consider designating set rooms for AGPs, so that non-AGP practice visits can continue in other

220 rooms without prolonged turnover times. Lastly, the incorporation of portable, industrial-grade

221 high efficiency particulate air (HEPA) filter units can be used in clinical rooms to provide the

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222 equivalent of additional air changes per hour and decrease the time a room needs closed

223 following an AGP.46

224 Future Considerations:

225 As rhinologists return to practice in the post-crisis phase, operational efficiencies will become

226 important. This will create a need for improvement in all areas including provider protection

227 with PPE, patient testing and protection, and physical plant optimization. Innovative options to

228 provide improvements in all three areas include creation of barrier pods that also minimize

229 aerosol and droplet dispersal. While these are currently available for use in the ICU and

230 intubation, special designing needs are necessary in the outpatient office that takes into

231 consideration patient safety, potential CO2 retention, ease of use and physician satisfaction.

232 Providers across the country are actively researching and developing various methods of barriers

233 to protect patient and staff that show promise.47-48

234

235 Conclusions

236 The SARS-CoV2 COVID-19 pandemic has resulted in world-wide changes in practices. As

237 rhinologists return to routine practice a multi-pronged approach is helpful to establish safe

238 practices for both providers and patients. These include pre-visit planning including

239 identification of high-risk procedures, appropriate choice of PPE, patient COVID-19 testing, and

240 physical facility management. Future directions for research may focus on innervations and

241 innovations that create safe, easy to use barriers in the out-patient clinical setting that protect

242 both the patient and the staff during high risk exams and procedures.

243

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392

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393 Figure 1:

394 AGPs = aerosol generating procedures; PPE = personal protective equipment

This manuscript has been accepted for publication in Otolaryngology-Head and Neck Surgery. Figure 1 Click here to access/download;Figure;Figure 1.jpg

This manuscript has been accepted for publication in Otolaryngology-Head and Neck Surgery.