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\begin{document}

\title{Tracheostomy time-out: a new safety tool in the setting of COVID-19}



\author[1]{Harish Dharmarajan, M.D.}%
\affil[1]{University of Pittsburgh Medical Center,}%


\vspace{-1em}



  
  \date{May 24, 2024}


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\selectlanguage{english}
\begin{abstract}
Tracheostomy procedures have a high risk of aerosol generation. Airway
providers have reflected on ways to mitigate the SARS-CoV-2 transmission
risks when approaching a surgical airway. To standardize institutional
safety measures with tracheostomy, we advocate using a dedicated
tracheostomy time-out applicable to all patients including those
suspected of having COVID-19. The aim of the tracheostomy time-out is to
reduce preventable errors that may increase the risk of transmission of
SARS-CoV-2.%
\end{abstract}%



\sloppy


\subsection*{\texorpdfstring{Harish Dharmarajan, M.D.\textsuperscript{1},
Carl H. Snyderman,
M.D.\textsuperscript{1}}{Harish Dharmarajan, M.D.1, Carl H. Snyderman, M.D.1}}

{\label{186506}}

\textsuperscript{1}Department of Otolaryngology, University of
Pittsburgh Medical Center, Pittsburgh, PA

\textbf{Corresponding Author} :

Harish Dharmarajan, M.D.

Department of Otolaryngology, UPMC

Eye \& Ear Institute, Suite 500

200 Lothrop Street

Pittsburgh, PA 15213

Email: dharmarajanh@upmc.edu. Phone: 3107365675.

\textbf{Funding} : There were no sources of funding for this project.

\textbf{Prior Presentations} : This project has not been presented or
published in prior meetings.

\textbf{Running} \textbf{Title} : Tracheostomy time-out

\textbf{Key} \textbf{Words} : tracheostomy, COVID-19, time-out, safety,
airway

\textbf{Abstract}

Tracheostomy procedures have a high risk of aerosol generation. Airway
providers have reflected on ways to mitigate the SARS-CoV-2 transmission
risks when approaching a surgical airway. To standardize institutional
safety measures with tracheostomy, we advocate using a dedicated
tracheostomy time-out applicable to all patients including those
suspected of having COVID-19. The aim of the tracheostomy time-out is to
reduce preventable errors that may increase the risk of transmission of
SARS-CoV-2.

\emph{Background}

The SARS-CoV-2 virus (severe acute respiratory syndrome coronavirus 2)
which causes COVID-19 infection (coronavirus disease 2019) has
dramatically changed the way that physicians approach airway procedures.
SARS-CoV-2 affects multiple levels of the aerodigestive tract. Viral
loads in the lower respiratory tract samples (sputum) appear to be
significantly higher compared to those from nasal or throat
swabs\textsuperscript{1}. Although the exact route of transmission is
not well defined, SARS-CoV-2 is thought to be spread via a combination
of contact, droplet, and airborne routes\textsuperscript{2}. The Centers
for Disease Control and Prevention has recommended use of personal
protective equipment for both patients and healthcare personnel in order
to decrease risk of transmission; this entails that patients use
facemasks and providers utilize isolation gowns, gloves, N95
respirators, and face shields or goggles\textsuperscript{3}. Commonly
performed airway procedures including intubation, direct laryngoscopy,
bronchoscopy, and tracheostomy placement have a high risk of aerosol
generation. Airway providers have reflected on ways to mitigate the
transmission risks especially when approaching a surgical airway.
Several academic organizations have outlined new recommendations for
tracheostomy placement in the setting of the COVID-19
pandemic\textsuperscript{4-7}. To standardize institutional safety
measures with tracheostomy, we advocate using a dedicated tracheostomy
time-out applicable to all patients including those suspected of having
COVID-19 (Figure 1). The aim of this specific tracheostomy time-out is
to reduce preventable errors that may increase the risk of transmission
of SARS-CoV-2 .

\emph{Elements of Transmission Risk Reduction}

In a tracheostomy procedure, risk reduction of SARS-CoV-2 transmission
can be broken down into three components: preparation, personnel, and
process (Figure 2).

\begin{enumerate}
\tightlist
\item
  \textbf{Preparation} . Patients who undergo an elective tracheostomy
  should receive pre-operative SARS-CoV-2 testing. In emergent airway
  settings however, this is not feasible. Several days before the
  procedure, the operating room or ICU coordinator must ensure that a
  negative pressure room is available and that appropriate personal
  protective equipment will be available for the entire OR staff. Before
  the procedure is started, we advocate that a dedicated tracheostomy
  time-out should be conducted. The time-out functions as a concise,
  standardized briefing between the Otolaryngology and Anesthesia teams
  as well as the rest of operative room staff. Key aspects of the case
  should be discussed at that moment including operative plan, paralytic
  and reversal plans, and expected sequences for holding ventilation or
  changing circuits. When the surgical team is close to entering the
  airway, there should again be a discussion with the anesthesia team
  regarding the expected next steps. A part of the tracheostomy time-out
  is focused on intra-operative safety measures (Figure 1, light magenta
  background); this portion of the time-out should be repeated when
  close to entering the airway.
\item
  \textbf{Personnel} . The surgical team personnel should be proficient
  at donning and removing PPE carefully. It is recommended that a
  spotter be assigned to ensure that providers are properly wearing PPE
  and do not accidently contaminate themselves while removing the PPE.
  Only the needed personnel should be present for the tracheostomy.
  Teamwork is essential, and open communication must be encouraged
  between all staff members during the procedure: surgeons,
  anesthesiologists, nursing staff, and surgical technologists.
  Personnel must feel comfortable with bringing forward any findings of
  error or mistakes. This is expected with any proper safety culture and
  climate.
\item
  \textbf{Process} . Both the surgical and anesthesiology teams must
  take steps to reduce the aerosolization of respiratory secretions
  during the case. One must also ensure that the ventilator does not
  become contaminated. Whenever the respiratory circuit is open,
  ventilation should be held. This is especially important after the
  tracheotomy incision is made. Ventilation should be held for the
  following sequence: endotracheal tube (ETT) advancement distally
  before tracheal incision, tracheal incision and withdrawal of ETT,
  tracheostomy tube insertion and cuff inflation, ventilation tubing
  attachment and closing of circuit. If ventilation is needed during
  this sequence, the surgical and anesthesiology teams should ensure
  that the cuff of the ETT or tracheostomy tube is first inflated. With
  any circuit changes, the anesthesia team clamps the ETT before
  reconnecting the circuit. Suctioning should be limited once the
  tracheotomy is made. If a bronchoscopy is needed after tracheostomy
  tube placement, we recommend using a side port and holding
  ventilation. A two-filter system is suggested by the Anesthesia
  Patient Safety Foundation; this involves using a viral filter at the
  ETT (or tracheostomy tube) and another at the expiratory limb of the
  ventilator circuit to prevent machine
  contamination\textsuperscript{8}. Additionally, a filter may be placed
  at the inspiratory circuit limb if there is concern that the machine
  itself may become contaminated in-between patient use. Permitting
  availability, we recommend that viral filters be placed on the
  patient's airway, ETT or tracheostomy tube, as well as both limbs of
  the respiratory circuit, inspiratory and expiratory. When
  transitioning from the ETT to tracheostomy circuit, the contaminated
  ETT viral filter should be discarded and a new filter should be placed
  at the tracheostomy tube. Once the patient can be weaned off the
  ventilator, an HME-filter should be used rather than leaving the
  tracheostomy tube open to trach mask.
\end{enumerate}

\emph{Tracheostomy Protocol at UPMC}

At the University of Pittsburgh Medical Center (UPMC), tracheostomy
placement in COVID-19 patients is considered only after 2-3 weeks of
mechanical ventilation unless there are compelling clinical reasons
necessitating earlier timing. All patients undergoing elective
tracheostomy receive pre-operative SARS-CoV-2 testing. As testing
capacity increases, retesting prior to the procedure is recommended. The
procedure should be performed in a negative pressure room for patients
who are COVID-19 positive or have an unknown status. Open surgical
tracheostomy is preferred to percutaneous dilation approach in order to
reduce the risk of aerosolization. The procedure is to be performed in
the ICU whenever possible to reduce exposure to staff and other
patients. Full PPE with N95 or powered air-purifying respirator (PAPR)
is required for all staff in the procedure room. The entire procedure is
done with complete paralysis and a high-flow suction device is
recommended whenever cautery is used. Ventilation is held when the
respiratory circuit is open. Tracheal suctioning is minimized and a
cuffed, non-fenestrated tracheostomy tube is always placed.

\emph{Survey of UPMC Tracheostomy Providers}

A brief survey focusing on tracheostomy practices during March and April
2020 was completed by Otolaryngologists, General Surgeons, and Thoracic
Surgeons at the UPMC Oakland campus. Providers were asked to respond how
often certain practices were being used during the procedure: always,
usually, about half the time, seldom, or never (Figure 3). In addition,
providers were asked to provide suggestions for tracheostomy time-out
design especially with regards to key safety measures. A total of 15
providers responded of which 9 had performed tracheostomies in this
timeframe (6 Otolaryngologists, 2 General Surgeons, and 1 Thoracic
Surgeon). Each provider performed an average of 3 tracheostomies (range:
1-6). None of the patients had confirmed COVID-19 infection although
four patients were under investigation at time of procedure. Most
providers (77\%; 7/9) performed open tracheostomies compared to
percutaneous approach. On average, two members of the surgical team were
present for the procedure (range: 1-3). Only one of the providers noted
using a negative pressure room for the tracheostomy. Most providers
reported always using the following practices: wearing an N95 mask
(66\%, 6/9), patient paralysis (66\%, 6/9), holding ventilation with
open respiratory circuit (77\%, 7/9), and using cuffed tracheostomy tube
(88\%, 8/9). Only three providers noted waiting for COVID-19 status
before performing the tracheostomy tube change. Providers frequently
performed the trach change between post-op days 5 to 10 (38\%, 3/8) or
after 10 days (38\%, 3/8); only 2 providers performed the trach change
on post-op day 5.

\emph{Tracheostomy Timeout Design and Feedback}

Airway providers provided various suggestions for tracheostomy time-out
design with a common emphasis on the following topics: COVID-19 status
verification, confirming PPE and equipment availability, coordination
with anesthesia team, paralytic and reversal plans, electrocautery
settings and FiO2 levels near airway, confirming anticipated periods of
holding ventilation with open circuit, avoiding tracheal suctioning
after tracheotomy, and use of viral filters for ventilator circuit, ETT,
and tracheostomy tube. These recommendations were used to create a
specific timeout targeting tracheostomy safety measures (Figure 1). The
tracheostomy time-out is conducted by the surgical team immediately
after completing the general surgical timeout. The middle portion of the
time-out, highlighted in the colored background, emphasizes
intra-operative safety measures to reduce risk of aerosolization and
airway fire; this portion is repeated when the surgical team is close to
entering the airway. A hardcopy of the time-out should available in the
operating room and be posted in a common area where both surgical and
anesthesiology teams can have access (i.e. side of anesthesia
workstation). Team debriefing is encouraged at the end of the case to
review what went well and assess for areas of improvement. The draft of
the time-out was sent to a total of 102 physicians for feedback: a mix
of Otolaryngologists, General Surgeons, Thoracic Surgeons, and
Anesthesiologists. There was an overall positive reception to the idea
of implementing a tracheostomy time-out. One provider noted that the
wording ``time-out'' may lead to confusion with the general surgical
time-out. In order to prevent any confusion, we added an opening
statement emphasizing that the tracheostomy time-out should follow the
completion of the general time-out. With continued use, we hope that
providers can easily integrate the tracheostomy time-out as an extension
of the general surgical time-out.

\emph{Implications for Patient and Provider Safety}

The origins of the surgical time-out can be traced back to safety
checklists used in the aeronautic industry\textsuperscript{9}. The
philosophy of usage influences how timeouts or checklists are
conducted\textsuperscript{10}. A procedural time-out may function as a
to-do list or as a backup process to verify tasks completed from memory.
The time-out is designed to protect against errors from memory recall.
There is usually a component of mutual redundancy in conducting a
time-out as multiple team members can monitor each other's
responses\textsuperscript{10}. Taking cues from other high reliability
organizations, the World Health Organization designed a surgical safety
checklist which resulted in reducing patient morbidity, mortality, and
complication rates\textsuperscript{11,12}. In the setting of the
COVID-19 pandemic, several academic organizations have released
guidelines on performing a tracheostomy. These recommendations are aimed
at safety measures to mitigate transmission risk of SARS-CoV-2. Given
the potential consequences for error, these standardized operating
practices for tracheostomy should not be carried out simply from memory
recall. Use of a dedicated tracheostomy time-out will allow for safety
measures to be verified in a consistent manner. There are several key
advantages to using the tracheostomy time-out: review of critical steps
by multiple team members, improvement in communication between OR
personnel, and an emphasis on quality control. Disadvantages include
possible time delays and checklist fatigue. In order to address this, we
have made the tracheostomy time-out focused and concise. If performed
without interruptions, the time-out can be completed in under 1 minute.

\emph{Next Steps}

In the coming weeks, we will widely implement this timeout process at
the UPMC Oakland campus. Adherence rates and provider feedback will be
tracked. In addition, the OR staff will observe several sessions of the
tracheostomy time-out by different providers to determine if any
adjustments can be made for ease of use. We will determine which parts
of the time-out are deemed important and if any parts appear
nonessential. A revised version will then be created and sent to
providers again for feedback.

References

\begin{enumerate}
\tightlist
\item
  Yu F, Yan L, Wang N, et al. Quantitative Detection and Viral Load
  Analysis of SARS-CoV-2 in Infected Patients. \emph{Clinical Infectious
  Diseases} . 2020. doi:10.1093/cid/ciaa345
\item
  Bahl P, Doolan C, Silva CD, Chughtai AA, Bourouiba L, Macintyre CR.
  Airborne or droplet precautions for health workers treating
  COVID-19?\emph{The Journal of Infectious Diseases} . 2020.
  doi:10.1093/infdis/jiaa189
\item
  Using Personal Protective Equipment (PPE). Centers for Disease Control
  and Prevention.
  https://www.cdc.gov/coronavirus/2019-ncov/hcp/using-ppe.html.
  Published April 3, 2020. Accessed April 20, 2020.
\item
  Parker N, Schiff B, Fritz M, et al. Tracheotomy Recommendations During
  the COVID-19 Pandemic. American Academy of Otolaryngology-Head and
  Neck Surgery.
  https://www.entnet.org/content/tracheotomy-recommendations-during-covid-19-pandemic.
  Published April 2, 2020. Accessed April 21, 2020.
\item
  Harrison L, Ramsden J, et al. Tracheostomy guidance during the
  COVID-19 Pandemic.
  https://www.entuk.org/tracheostomy-guidance-during-covid-19-pandemic.
  Accessed April 21, 2020.
\item
  Michetti CP, Burlew CC, Bulger EM, Davis KA, Spain DA. Performing
  tracheostomy during the Covid-19 pandemic: guidance and
  recommendations from the Critical Care and Acute Care Surgery
  Committees of the American Association for the Surgery of
  Trauma.~\emph{Trauma Surgery \& Acute Care Open} . 2020;5(1).
  doi:10.1136/tsaco-2020-000482
\item
  Schultz P, Morvan J-B, Fakhry N, et al. French consensus regarding
  precautions during tracheostomy and post-tracheostomy care in the
  context of COVID-19 pandemic.~\emph{European Annals of
  Otorhinolaryngology, Head and Neck Diseases} . 2020.
  doi:10.1016/j.anorl.2020.04.006
\item
  Feldman J, Loeb R, Philip J. FAQ on Anesthesia Machine Use,
  Protection, and Decontamination During the COVID-19 Pandemic.
  Anesthesia Patient Safety Foundation.
  https://www.apsf.org/faq-on-anesthesia-machine-use-protection-and-decontamination-during-the-covid-19-pandemic/.
  Accessed April 21, 2020.
\item
  Newkirk JD. Preventing Surgical Mishaps.~\emph{Clinics in Plastic
  Surgery} . 2013;40(3):475-487. doi:10.1016/j.cps.2013.04.011
\item
  Degani A, Wiener EL. Cockpit Checklists: Concepts, Design, and
  Use.~\emph{Human Factors: The Journal of the Human Factors and
  Ergonomics Society} . 1993;35(2):345-359.
  doi:10.1177/001872089303500209
\item
  Weiser TG, Haynes AB, Lashoher A, et al. Perspectives in quality:
  designing the WHO Surgical Safety Checklist.~\emph{International
  Journal for Quality in Health Care} . 2010;22(5):365-370.
  doi:10.1093/intqhc/mzq039
\item
  Haynes AB, Weiser TG, Berry WR, et al. A Surgical Safety Checklist to
  Reduce Morbidity and Mortality in a Global Population.~\emph{New
  England Journal of Medicine} . 2009;360(5):491-499.
  doi:10.1056/nejmsa0810119
\end{enumerate}

\par\null\par\null\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/HED-20-0626--Figure-1-Final-HD/HED-20-0626--Figure-1-Final-HD}
\caption{{This is a caption
{\label{823301}}%
}}
\end{center}
\end{figure}

\textbf{Figure 1} . Tracheostomy time-out. This is performed immediately
after the general surgical time-out is completed. The middle of the
checklist highlighted in light magenta background involves
intraoperative safety measures which should be repeated when the
surgical team is close to entering the airway. PPE: personal protective
equipment. ETT: endotracheal tube. FiO2: fraction of inspired oxygen via
anesthesia circuit. HME: heat moisture exchanger.

\par\null\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/HED-20-0626-Figure-2-Final-HD/HED-20-0626-Figure-2-Final-HD}
\caption{{This is a caption
{\label{628685}}%
}}
\end{center}
\end{figure}

\textbf{Figure 2} . Summary of risk reduction measures for performing a
tracheostomy. Pre-OP: pre-operative period. PPE: personal protective
equipment. ETT: endotracheal tube. FiO2: fraction of inspired oxygen via
anesthesia circuit. HME: heat moisture exchanger.

\par\null\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/HED-20-0626-Figure-3-Final-HD/HED-20-0626-Figure-3-Final-HD}
\caption{{This is a caption
{\label{485501}}%
}}
\end{center}
\end{figure}

\textbf{Figure 3} . Provider survey of tracheostomy practices in March
and April 2020. Responses are from 9 providers across UPMC
Otolaryngology, General Surgery, and Thoracic Surgery. None of the
patients had confirmed COVID-19 infection but 4 patients were under
investigation at time of procedure. PAPR: powered air-purifying
respirator. ETT: endotracheal tube.

\selectlanguage{english}
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