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\begin{document}

\title{Procedural~ Precautions and Personal Protective Equipment during Head
and Neck~ Instrumentation in the COVID-19 Era~~~~~}



\author[1]{Jason Y K Chan, FRCSEd (ORL)}%
\affil[1]{The Chinese University of Hong Kong}%


\vspace{-1em}



  
  \date{May 21, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Background: Otolaryngologists represent a subset of healthcare workers
uniquely vulnerable to COVID-19 transmission. Given the segmentation of
extant guidelines concerning precautions and protective equipment for
SARS-CoV2, we aimed to provide consolidated recommendations regarding
appropriate personal protective equipment (PPE) in head neck surgery
during the COVID-19 era.

Methods: Guidelines published by international and United States
governing bodies were reviewed in conjunction with published literature
concerning COVID-19 transmission risk, testing, and PPE, to compile
situation-specific recommendations for head and neck providers managing
COVID-19 patients.

Results: High-quality data regarding the aerosolization potential of
head and neck instrumentation and appropriate PPE during head and neck
surgeries are lacking. However, extrapolation of recommendations by
governing bodies suggest strongly that head and neck mucosal
instrumentation warrants strict adherence to airborne-level precautions.

Conclusion: We present a series of situation-specific recommendations
for PPE use and other procedural precautions for otolaryngology
providers to consider in the COVID-19 era.%
\end{abstract}%



\sloppy


\subsection*{\texorpdfstring{Bharat A. Panuganti, MD\textsuperscript{1*};
John Pang, MD\textsuperscript{1*}; Joseph Califano,
MD\textsuperscript{1}; Jason Y K Chan, FRCSEd
(ORL)\textsuperscript{2}.}{Bharat A. Panuganti, MD1*; John Pang, MD1*; Joseph Califano, MD1; Jason Y K Chan, FRCSEd (ORL)2.}}

{\label{727459}}

\textsuperscript{1}University of California-San Diego, Department of
Surgery, Division of Otolaryngology-Head and Neck Surgery, San Diego,
CA, USA.

\textsuperscript{2}The Chinese University of Hong Kong, Department of
Otorhinolaryngology, Head and Neck Surgery, Shatin, Hong Kong.

\textbf{~}\emph{Bharat A. Panuganti and John Pang are co-first authors.}

\textbf{~Corresponding Authors:}

\textbf{Jason Y K Chan, FRCSEd (ORL)}

\textsuperscript{2}The Chinese University of Hong Kong, Department of
Otorhinolaryngology, Head and Neck Surgery, Shatin, Hong Kong

E-Mail: jasonchan@ent.cuhk.edu.hk

\textbf{Joseph Califano}

Division of Otolaryngology--Head and Neck Surgery, Department of
Surgery, University of

California--San Diego

3855 Health Sciences Dr, MC 0803, La Jolla, CA 92037-0803, USA.

Email: jcalifano@ucsd.edu

\textbf{Running Title:} Precautions and PPE in Head and Neck Surgery
during COVID-19

\textbf{Keywords:} COVID-19, personal protective equipment, high-risk
procedures, perioperative protocols\textbf{~}

\textbf{Abstract}

\textbf{Background:} Otolaryngologists represent a subset of healthcare
workers uniquely vulnerable to COVID-19 transmission. Given the
segmentation of extant guidelines concerning precautions and protective
equipment for SARS-CoV2, we aimed to provide consolidated
recommendations regarding appropriate personal protective equipment
(PPE) in head neck surgery during the COVID-19 era.

\textbf{Methods:} Guidelines published by international and United
States governing bodies were reviewed in conjunction with published
literature concerning COVID-19 transmission risk, testing, and PPE, to
compile situation-specific recommendations for head and neck providers
managing COVID-19 patients.

\textbf{Results:} High-quality data regarding the aerosolization
potential of head and neck instrumentation and appropriate PPE during
head and neck surgeries are lacking. However, extrapolation of
recommendations by governing bodies suggest strongly that head and neck
mucosal instrumentation warrants strict adherence to airborne-level
precautions.

\textbf{Conclusion:} We present a series of situation-specific
recommendations for PPE use and other procedural precautions for
otolaryngology providers to consider in the COVID-19 era.

rocedural Precautions and Personal Protective Equipment during Head and
Neck Instrumentation in the COVID-19 Era

\textbf{Introduction}

The COVID-19 pandemic has afflicted more than 1.8 million individuals in
over 183 countries and territories, prompting widespread debate about
the mechanisms of disease transmission, personal protection against
spread, and treatment methods. \textsuperscript{1} Healthcare workers
represent a uniquely vulnerable population, given their close proximity
to infected patients in settings with abundant fomites, with further
increased risk in the setting of aerosol-generating procedures (AGP).
Scope of practice in otolaryngology necessitates instrumentation of the
upper aerodigestive tract, wherein significant viral loads are found in
both symptomatic and asymptomatic patients. As such, in the absence of
widespread screening, otolaryngologists are at heightened risk of
SARS-CoV2 contraction in common practice. For healthcare workers, the
use of adequate personal protective equipment (PPE) is crucial for the
protection of both patients and providers. In fact, during the SARS-CoV1
epidemic, healthcare workers who used PPE inconsistently were more
likely to develop SARS-CoV1.\textsuperscript{2} In light of the
widespread shortage of PPE and the high, relative risk of transmission
during head and neck procedures (via mucus, blood, or aerosolized
virions), we present situation-specific guidelines for PPE use by
otolaryngologists during the COVID-19 pandemic, based on our compilation
and collective interpretation of existing recommendations and
data.\textsuperscript{3}

\textbf{Overview of Method of Transmission/PPE}

The World Health Organization recognizes COVID-19 as a droplet-borne
disease unless an aerosol-generating procedure is performed (e.g.
non-invasive positive pressure ventilation, bronchoscopy, open
suctioning, endotracheal intubation, cardiopulmonary resuscitation,
tracheostomy, and administration of nebulized treatment). Currently,
coughing and sneezing are categorized as droplet-producing, not
aerosolizing, by both the Centers for Disease Control (CDC) and World
Health Organization (WHO). Droplet transmission occurs via respiratory
droplets between 5-10 micrometers when an at-risk individual is within 1
meter of the source. Airborne transmission occurs in so-called droplet
``nuclei'' measuring fewer than 5 micrometers capable of traveling for
distances greater than 1 meter, such as the case during AGPs. While
several publications have reported SARS-CoV2 aerosolization risk with
coughing or sneezing, although, so far, the WHO has maintained that
additional research is necessary to verify these claims, citing issues
either with using RNA detection as a proxy for the presence of viable
virus, or the method by which inoculum was
aerosolized.\textsuperscript{4--6}

Loose-fitting, standard surgical facemasks, together with a face-shield
or eye protection, are considered protective against droplets.
Fit-tested N95 filtering facepiece respirators, along with tight-fitting
eye protection or face-shields with side protection to shield the
conjunctiva are indicated for providers when there is a risk for
airborne transmission. Powered air-purifying respirators (PAPR)
represent a reusable alternative to N95s for protection against airborne
transmission. Although there is a quantitative difference in the
filtering efficacy of N95 filtration masks (assigned protection factor
{[}APF{]} of 10, indicating that 90\% of airborne particles are blocked
from inhalation) versus PAPR (APF of up to 1000 for a full facepiece
PAPR), neither the CDC nor the WHO have clearly characterized a
clinically-discernible difference with standard use.
\textsuperscript{7}While the N95 requires mask-fit testing, PAPR
requires training to guide proper assembly and troubleshooting of
components (e.g. battery, hose, filter, etc.), donning and doffing, and
may pose unique visibility issues (e.g. fogging, inability to use
headlight) in the operating room. Moreover, headaches are common amongst
healthcare workers wearing N95 masks \textsuperscript{8}, a phenomenon
postulated to be related to impaired gas exchange with retention of
carbon dioxide, or mechanical factors associated with prolonged N95 mask
usage. \textsuperscript{9}

\textbf{Testing}

History and physical exam alone are often insufficient to guide PPE and
procedural decision-making, as up to 80\% of patients may be mildly
symptomatic or asymptomatic COVID-19 carriers. \textsuperscript{1011}
Clear protocols to advise testing, with accommodations for limitations
in resources, are therefore important to appropriately protect providers
and patients against transmission.

As it stands, there is no ``gold standard test''; negative results do
not preclude SARS-CoV2 infection and should not be used as the sole
basis for patient management decisions (West CP). Rather, symptoms,
history, and test findings should be used together to guide assessment
of COVID-19 status.\textsuperscript{12} In otolaryngology, COVID-19
status (known or inferred) is integral to direct appropriate PPE for all
involved staff in the operating room or clinic setting. Currently, the
most available molecular diagnostic tests are real-time
reverse-transcription polymerase chain reaction assays for two or more
viral targets. However, as there are concerns for the low sensitivity
and negative predictive value of a single test, a combination of two PCR
tests or the addition of chest CT to the diagnostic algorithm have been
suggested to improve sensitivity, although this combination may not be
universally feasible in the preoperative setting.\textsuperscript{13}The
current negative predictive value of each test is variable, but guidance
for de-isolation of infected patient includes at least two upper
respiratory tract samples negative for SARS-CoV-2 collected at least 24
hours apart by the European Centre for Disease Prevention and Control
and the Department of Health of Hong Kong. This testing approach may
potentially be used as testing kit availability and result turnaround
times improve to screen patients for elective
surgery.\textsuperscript{14}

\textbf{PPE for Airway Procedures}

Otolaryngologists are commonly involved in AGPs requiring open or
endoscopic airway instrumentation, including tracheostomy, direct
laryngoscopy with interventions, and endotracheal intubation. A
systematic review meant to assess the relative risk of transmission of
SARS-CoV1 during a spectrum of AGPs found endotracheal intubation (odds
ratio {[}OR{]}=6.6) and tracheostomy (OR=4.2) to be among the
highest-risk procedures.\textsuperscript{15} On April 2, the American
Academy of Otolaryngology (AAO) released an updated position statement
recommending against elective tracheostomy within the first 2-3 weeks
following intubation, in patients with high-pressure ventilatory
requirements, and in patients without COVID-19
testing.\textsuperscript{16} Moreover, there is little existing evidence
suggesting a definitive overall survival benefit associated with early
tracheostomy among critically-ill patients.\textsuperscript{17} As such,
the theoretical remaining benefits of early, elective tracheostomy (e.g.
laryngotracheal morbidity) must be carefully weighed against the known
risk of SARS-CoV2 transmission during tracheotomy procedures, when the
option to bide time until viral clearance or ventilatory independence
occurs. However, if patient circumstances (e.g. bulky head and neck
tumor) necessitate a tracheostomy or elective tracheostomy is performed,
appropriate PPE is strictly necessary.

PPE for tracheostomy procedures should abide by airborne-level
precautions, which include an N95 mask with eye protection or PAPR,
surgical cap, long-sleeved waterproof surgical gowns, gloves, and
shoe/leg covers to prevent tracking. Some groups, cultivating their
experience from treatment of either SARS-CoV1 or SARS-CoV2 patients,
have advocated for enhanced PPE during high-risk, airway procedures,
such as tracheostomy, including full face-shields or helmets with full
face coverage and double gloves, or concomitant N95 and PAPR
use.\textsuperscript{18,19} Other important considerations include 1)
possibility of performing open tracheostomy in a negative-pressure room
in the intensive care unit, to minimize unnecessary ventilatory circuit
manipulation for patient transport; 2) complete muscular paralysis, when
permitted (i.e. not awake tracheostomy), during the procedure to
minimize coughing with an open airway; 3) minimization of electrocautery
to mitigate the potential transmission of aerosolized virions through
smoke\textsuperscript{20}, and, 4) use of a closed tracheal suction
system with a viral filter. While percutaneous tracheostomy can be
considered as an alternative to intraoperative open tracheostomy, there
may be similar, if not more significant, risk of aerosolization given
the need for bronchoscopy and serial instrumentation of the airway for
dilation.\textsuperscript{21} If awake tracheostomy cannot be avoided,
additional unique considerations include adequate local anesthesia to
prevent patient movement during the procedure, and a patient surgical
facemask, with low-flow oxygen administration via nasal cannula, if
necessary, to reduce large droplet transmission with coughing. Routine
tracheostomy tube exchanges should be delayed in COVID-19 patients to
limit airway manipulation; instead, simple cuff deflation should be
considered to reduce mucosal irritation and facilitate phonation. If
exchange is performed, standard airborne-level PPE (N95, eye protection
or full faceshields, surgical gown, and gloves) should be donned by
participating providers, including nurses and respiratory therapists.

Though specific guidelines have not been formulated for suspension
microlaryngoscopy, the procedure exposes the distal airway with positive
pressure ongoing (albeit with a seal created by the endotracheal tube
cuff), and involves instrumentation of the respiratory mucosa. Given the
CDC's current characterization of intubation and bronchoscopy as
``high-risk'' procedures (i.e. either aerosolizing or associated with
poor control of respiratory secretions), airborne precautions should be
strongly considered for suspension microlaryngoscopy if surgery cannot
be delayed (e.g. laryngeal cancer with marginal endoscopic
resectability).\textsuperscript{22} Use of laser is common during
microlaryngoscopic procedures; the risk of human papilloma virus (HPV)
transmission has been studied in this setting. A study by Kunachack et
al. found that no viable HPV virions could be cultured from CO2 laser
plume.\textsuperscript{23} Another study by Ferenczy et al. found HPV
DNA in the prefilter section of the smoke evacuator used to clear the
surgical field of the laser plume; the inner, postfilter sections of the
smoke evacuator, however were devoid of viral
DNA.\textsuperscript{24}While iatrogenic inoculation of the surgeon is
not a widely reported phenomenon in the treatment of HPV related
disease, it is unclear if empirical measures, including use of a smoke
evacuator with a high-efficiency filter, or prior research concerning
HPV would be applicable to SARS-CoV2. Lastly, jet ventilation should be
avoided, if possible, given the procedure's high applied pressure
without an inflated cuff as a barrier to aerosolized virions. (Table 1)

Unless the otolaryngologist is required in the operating room during
endotracheal intubation of COVID-positive or suspicious patients (e.g.
if the risk of a surgical airway is high), only anesthesia providers
should be present during intubation with appropriate PPE donned. A
statement issued by the American Society of Anesthesiologists
recommended standard airborne-level PPE (N95 respiratory with eye
protection or facial protection covering the sides of the face versus
PAPR, waterproof gown, and gloves) be worn by providers present during
intubations for patients with confirmed or suspected
COVID-19.\textsuperscript{25} Additional recommendations for the
intubating provider include use of videolaryngoscopy to allow for
greater distance between the provider and the patient and prompt
inflation of the endotracheal tube cuff after passage through the vocal
cords to create a seal before initiation of positive pressure
ventilation.

\textbf{PPE for Endoscopic Sinus or Skull Base Surgery}

The nasopharynx and nasal cavity are known to harbor significant viral
loads, and in concentrations potentially proportionate to the severity
of COVID-19 symptoms.\textsuperscript{26} In a commonly cited case, a
patient with either no symptoms or mild flu symptoms in Wuhan underwent
a trans-sphenoidal pituitary surgery in January 2020; 14 healthcare
workers who were involved in the patient's care (either in the operating
room or outside of it) were reported to have tested positive for
COVID-19. The precise circumstances surrounding exposure of the 14
healthcare workers, however, are uncertain, and their COVID-19
positivity may or may not have been due to their interaction with the
patient who underwent the trans-sphenoidal procedure. The CDC currently
characterizes open suctioning in a COVID-19 positive patient as an AGP;
as such, endoscopic transnasal procedures (e.g. endoscopic sinus
surgery), with suctioning and concomitant mucosal instrumentation in a
florid field, should warrant at least standard airborne-level PPE. In
fact, the CDC recommends an N95 or higher-level respiratory for
providers obtaining nasopharyngeal swabs in COVID-19-suspicious
patients, resources permitting, reflecting the greater relative degree
of caution the CDC exercises with nasal or nasopharyngeal
instrumentation.\textsuperscript{22} (Table 1)

\textbf{PPE for surgery of the neck without airway or mucosal exposure}

Although surgical procedures including cold steel incision and
dissection, suction, and cautery can theoretically aerosolize blood and
tissue particles\textsuperscript{27}, the potential for SARS-CoV2 virus
aerosolization appears to be minimal outside the setting of the upper
aerodigestive tract. In fact, COVID-positive patients demonstrated no
detectable serum SARS-CoV2 RNA, compared to sputum analysis which
produced 7 x 10\textsuperscript{6} -- 2.35 x
10\textsuperscript{9}copies/ml \textsuperscript{28}. Therefore, the
extant literature suggests that standard surgical precautions are
sufficient for surgery involving the neck without mucosal membrane
exposure in COVID-positive patients. Accordingly, it may be recommended
that providers exposed to the surgical field (surgeons, surgical
assistants, and surgical technologists) wear standard PPE for surgeries
(e.g. neck dissections) without airway or mucosal exposure (i.e.
loose-fitting surgical mask, gloves, eye shield, and surgical gowns).
(Table 1)

\textbf{PPE for Otologic Surgery}

Data concerning viral burden in the middle ear and mastoid cavity is
lacking, though historical studies have found coronavirus RNA in middle
ear fluid. \textsuperscript{29} Recommendations have been made for
enhanced eye (i.e. tight-fitting goggles or PAPR) protection when
drilling is performed, which have been related to reports of
transcorneal penetration of bone dust during mastoidectomy demonstrated
in an experimental setting \textsuperscript{30}, and the distinct
uncertainty surrounding, but persistent suspicion of, viral
aerosolization with bone drilling. In light of the available data, at
least standard airborne precautions should be followed on COVID-positive
or suspicious patients undergoing otologic surgery.

\textbf{Outpatient clinic}

The use of PPE for COVID-positive or suspected patients in the
outpatient setting may be dictated by the nature of the patient
interaction. As previously noted, the CDC advises airborne-level
precautions (i.e. N95 or higher-level respirator, eye protection,
gloves, and gown), and consideration of negative-pressure room, when
performing aerosol-generating procedures.\textsuperscript{7} Some in
vitro evidence has been interpreted to suggest that flexible nasal
endoscopy, for example, while not intrinsically an AGP, may lead to
aerosol generation via coughing or sneezing.\textsuperscript{31} As
previously mentioned, however, the WHO classifies coughing and sneezing
as droplet-generating, not aerosolizing, events. However, nasal
endoscopy with suctioning would be classified as an AGP by the CDC,
warranting airborne-level precautions.\textsuperscript{22} Standard head
and neck physical examinations of putative or positive COVID-19 patients
require droplet-level precautions, ensuring appropriate eye protection,
given the need for close inspection of the nasal and/or oral cavities
and potential proximity to droplet transmission with expectoration.
(Table 1)

\textbf{Conclusion}

Despite the persistent uncertainty surrounding the anticipated
trajectory of COVID-19, and the precise risk profile associated with
head and neck procedures, it behooves otolaryngologists to practice
responsible PPE use and abide by procedural precautions (e.g. active
preoperative testing, delaying non-emergent cases) for the safety of
both providers and patients. Herein, we present recommendations for
otolaryngologists practicing in both the outpatient and inpatient
settings that are summarized in table 1. While the medical community's
understanding of SARS-CoV2 continues to evolve, the consistent
observation of safety measures is critical to limit propagation of
COVID-19 in the healthcare setting.



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