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\begin{document}

\title{Tracheotomy in COVID-19 patients:~ Optimizing patient selection and~
identifying prognostic indicators}



\author[1]{Thomas James Stubington, MD}%
\affil[1]{Royal Derby Hospital}%


\vspace{-1em}



  
  \date{May 15, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
Background

Tracheotomy, through its ability to wean patients off ventilation, can
shorten ICU length of stay and in doing so increase ICU bed capacity,
crucial for saving lives during the COVID-19 pandemic. To date, there is
a paucity of patient selection criteria and prognosticators to
facilitate decision-making and enhance precious ICU capacity.

Methods

Prospective study of COVID-19 patients undergoing tracheotomy (n=12)
over a 4-week period (March-April 2020). Association between pre- and
post- operative ventilation requirements and outcomes (ICU stay, time to
decannulation, and death) were examined.

Results

Patients who sustained FiO2[?]50\% and PEEP[?]8cm H2O in the 24h
pre-tracheotomy exhibited a favourable outcome. Those whose requirements
remained below these thresholds post-tracheotomy could be safely stepped
down after 48h.

Conclusion

Sustained FiO2[?]50\% and PEEP[?]8cm H2O in the 48h post-tracheotomy are
strong predictive factors for a good outcome, raising the potential for
these patients to be stepped down early, thus increasing ICU capacity.%
\end{abstract}%



\sloppy


\textbf{Thomas J. Stubington . 1 , Ali S Mallick, Georgios Garas 3 ,
Emma Stubington . 4 , Chetan Reddy . 5 , Mohammed S Mansuri . 6 ~}

\begin{enumerate}
\tightlist
\item
  MBBS BMedSci MRCS(ENT) PGCert (MedEd), Department of
  Otorhinolaryngology - Head and Neck Surgery, Royal Derby Hospital,
  Uttoxeter Road, Derby, DE22 3NE, United Kingdom
\item
  MBBS MRCS (DOHNS) PhD, Department of Otorhinolaryngology - Head and
  Neck Surgery, Royal Derby Hospital, Uttoxeter Road, Derby, DE22 3NE,
  United Kingdom
\item
  PhD FRCS FEBORL-HNS, Department of Otorhinolaryngology - Head and Neck
  Surgery, Nottingham University Hospitals NHS Trust, Queens Medical
  Center Campus, Nottingham, NG7 2UH, United Kingdom
\item
  BSc, Mres, PhD STOR-I Centre for Doctoral Training, Lancaster
  university, UK
\item
  MBBS FANZCA, Department of Anaesthesia, Royal Derby Hospital,
  Uttoxeter Road, Derby, DE22 3NE
\item
  MBChB, Msc, Dip (RMES), FRCS (ORL), Department of Otorhinolaryngology
  - Head and Neck Surgery, Royal Derby Hospital, Uttoxeter Road, Derby,
  DE22 3NE, United Kingdom
\end{enumerate}

Corresponding Author: Thomas James Stubington, Dept. Head and Neck
Surgery, Royal Derby Hospital, Uttoxeter Road, Derby, DE223NE
Thomas.stubington@nhs.net

Short Title

Prognostic indicators for Tracheotomy in Covid-19 Patients.

Keywords

SARS-CoV-2, Coronavirus, COVID-19, Pandemic, Tracheotomy

\par\null

Introduction

Coronavirus disease 2019 (COVID-19) has rapidly evolved into a pandemic
since the first report emerged from China in December
2019\textsuperscript{1}. With the number of cases rising globally at an
exponential rate and with over 10\% of these requiring Intensive Care
Unit (ICU) admission, demand for critical care increasingly threatens to
exceed capacity even among the world's most advanced
economies\textsuperscript{2}. At present, supportive treatment forms the
basis of therapy, with trials currently ongoing to unearth the optimal
medicinal treatment regimen and vaccine. Tracheotomy, through its
ability to wean patients off ventilation, can shorten the ICU length of
stay and in doing so increase ICU bed capacity; crucial for saving lives
at a population level. \textsuperscript{3,4} Median ICU stay for
COVID-19 patients varies widely between countries ranging between 4 to
over 20 days. \textsuperscript{5}

Tracheotomy constitutes an Aerosol Generating Procedure (AGP), thus
potentially exposing the operating surgeon and Operating Room (OR) team
to respiratory droplets from the SARS-CoV-2 infected
patient\textsuperscript{6}. With this added risk in mind it is vital
that the potential benefits of a reduced ICU stay associated with
performing a tracheotomy are balanced against the risks to healthcare
professionals. Despite a number of authors having already published
guidelines to minimize risks to healthcare personnel when performing
tracheotomy in the COVID-19 positive patient\textsuperscript{7-11},
there is currently a paucity of literature on patient selection criteria
for this procedure and outcomes data for patients who have undergone
tracheotomy in these circumstances. To address this, we present our data
from the first 12 COVID-19 patients that underwent tracheotomy in our
institution, and propose parameters to inform patient selection by
identifying those patients who may be more likely to benefit from the
procedure. Furthermore, we discuss potential predictive factors that may
help clinicians identify at an early stage (48h post-operatively) those
patients who are likely to have a positive outcome post-tracheotomy,
which may facilitate decisions to step-down patient care and thus
improve the availability of critical care resources to those patients
that need it most.

Methods

This was a prospective study of all COVID-19 patients undergoing
tracheotomy (n=12) in a Head \& Neck Unit in the United Kingdom during a
4-week period (March-April 2020). Anesthesiological processes and
surgical steps pre- and peri-tracheostomy insertion were standardised to
minimise risk to staff and improve patient safety during this crucial
part of the procedure (see Supplementary Material). Recordings of the
patient's Fraction of Inspired Oxygen (FiO\textsubscript{2}) and Peak
End Expiratory Pressure (PEEP) were obtained for the 24 hours preceding
the procedure, and subsequently collected on a daily basis until the
patient was either decannulated and discharged from hospital, or died.
Fluctuations in these values, which occurred due to patient
intervention/movement were removed in order to facilitate calculation of
representative averages for these values. The number of days that
patients were kept under sedation and number of days taken for
decannulation were also recorded.

Following our experience with our first 5 tracheotomies and in
accordance with our local protocol (see Supplementary Material) and
published literature \textsuperscript{7--9},we instituted selection
criteria for all subsequent tracheotomies as follows:

\begin{itemize}
\tightlist
\item
  Patients should ideally be at least 14 days post-positive swab result
\item
  Low oxygen requirements (FiO\textsubscript{2}[?]40\%), sustained for at
  least 24 hours
\item
  Patient able to tolerate clamped tube for 1 min in ICU (`clamp test')
\item
  Two failed trials of sedation withholding prior to considering
  tracheotomy
\item
  Patients that will not require prone ventilation
\end{itemize}

Correlation between data sets was determined using the `R' statistical
software (v3.6.1, \selectlanguage{ngerman}© The R Foundation, Vienna, Austria). Data were
ranked, and Spearman's rank correlation coefficient was calculated to
determine association between data sets.

\section*{Results}

{\label{results}}

In total, 12 COVID-19 patients underwent surgical tracheotomy over a
4-week period (March-April 2020), of which two died (patients B and C).
Patient B had FiO\textsubscript{2} values ranging between 81-90\% in the
24 hours before tracheotomy, whilst patient C had their tracheotomy
performed 4 days after having a positive swab result. Of the remaining
patients that survived, patients D and E took the longest to be
decannulated, both of whom had pre-operative FiO\textsubscript{2} values
\selectlanguage{english}[?]50\%, as well as high PEEP values (Table 1).

The data suggest that a patient's pre-operative status in the 24 hours
preceding the procedure may highlight those patients likely to benefit
from tracheotomy. Figure 1 illustrates each patient's pre-operative
FiO\textsubscript{2} concentration and PEEP requirements in the format
of a bubble plot, which suggests that an FiO\textsubscript{2} of \selectlanguage{english}[?]50\%
with a PEEP of \selectlanguage{english}[?]8cm of H\textsubscript{2}O in the 24 hours preceding
tracheotomy may be associated with a worse outcome, as the patients that
did not fulfil these criteria in the 24 hours preceding tracheotomy
either died or had a prolonged wean of ventilation despite the
procedure.

Cumulative data suggested that patients requiring an
FiO\textsubscript{2} of \selectlanguage{english}[?]50\% and PEEP of \selectlanguage{english}[?]8cm of H\textsubscript{2}O in
the first 48 hours following tracheotomy tended to have a more favorable
outcome compared to those exceeding these values. To examine this in
greater depth, the proportion of time for each patient at which the PEEP
was \selectlanguage{english}[?]8cm H\textsubscript{2}0 and the proportion of time
FiO\textsubscript{2} was \selectlanguage{english}[?]50\% across all days were calculated
regardless of length of follow-up. From this, the average proportion of
time that PEEP was \selectlanguage{english}[?]8cm H\textsubscript{2}0 and average proportion of
time that FiO\textsubscript{2}\selectlanguage{english}[?]50\% were calculated, with the patients
subsequently ranked accordingly. These steps were then repeated but with
only looking at the data for up to day 2 post-tracheotomy to look for
early prognostic indicators (see Supplementary Figures 1 and 2). The
ranks for both parameters were then plotted on a scatter plot (Figure
2), which illustrates that rank at day 2 post-tracheotomy strongly
correlates with rank from all days, and therefore with the patient's
final outcome (\selectlanguage{greek}ρ\selectlanguage{english}=0. 955, P\textless{}0.05).

Discussion

This is the first report of patient outcomes following tracheotomy in
COVID-19 patients, and on the basis of our institutional experience we
propose criteria that offer a pragmatic solution to facilitate patient
care whilst minimizing risks to healthcare workers.

Given the risk that tracheotomy in COVID-19 patients poses to healthcare
workers through aerosolization of SARS-CoV-2 virions, it is paramount
that these risks are carefully balanced against potential benefits to
patient care. Concerns around infection in COVID-19 patients stem from
previous experience from SARS-CoV, which posed a particular risk to
healthcare workers as peak viral load tended to occur 7-10 days
post-infection \textsuperscript{10}. In contrast, COVID-19 patients
appear to have the highest viral load at the onset of infection and this
subsequently declines over time, which may account for the speed at
which this novel coronavirus is spreading within the
community\textsuperscript{11}. Furthermore, although it has been shown
that SARS-CoV-2 RNA can be detected in patients up to 20 days or longer
post-infection, it is unclear whether this represents patients shedding
live virus, or if this reflects shedded virions inactivated by host
antibodies \textsuperscript{11}. In the context of planning a
tracheotomy, this has two important implications; first, a positive test
does not reflect the degree of infectivity of a patient, and second, on
the basis of current data we can draw a cautious degree of reassurance
that patients are likely to be less infectious the further away they are
from their initial presentation. Thus, we believe that undertaking a
tracheotomy at least 14 days following a positive swab result, in
conjunction with wearing full Personal Protective Equipment (PPE) and
taking all the necessary steps to minimize aerosolization
peri-tracheotomy insertion (see Supplementary Material) presents a
pragmatic solution to minimizing risk to staff. To date, none of the OR
staff who have been involved with undertaking tracheotomies in COVID-19
patients has tested positive for the disease in our institution.

In light of the relative uncertainties that exist in the treatment of
patients with COVID-19, patient selection for tracheotomy will
ultimately be refined through experience. The selection criteria
proposed in this study (FiO\textsubscript{2}[?]50\% and PEEP[?]8cm of
H\textsubscript{2}O in the 24 hours prior to the tracheotomy) were
derived on the basis of our early experience with the first five
COVID-19 tracheotomies; of which, one survived (patient A), two died
(patients B and C) and the remaining two had a prolonged wean off the
ventilator (patient D, who was taken off ventilation at day 17
post-procedure, and patient E, who continues to be on ventilation at the
time of writing). Of the 4 patients who had less favorable outcomes,
three had either an FiO\textsubscript{2}[?]50\% or a PEEP requirement
exceeding 8cm H\textsubscript{2}O. The `anomaly' was patient C who
despite being within an acceptable range for both
FiO\textsubscript{2}and PEEP unfortunately died. In retrospect, this
patient probably had their tracheostomy too early at day 4
post-intubation; it is thus vital that ICU teams liaise closely with
surgical teams when identifying potential candidates for tracheotomy,
and put forward those patients who have demonstrated improvement in
their clinical course.

From this study, two important findings emerge in terms of the
prognostic value of ventilation-related parameters prior to tracheotomy.
These are an FiO\textsubscript{2} requirement [?]50\% and PEEP[?]8cm
H\textsubscript{2}O in the 24 hours prior to tracheotomy with all
patients exceeding these cut off values either experiencing a prolonged
wean and dying or failing to improve and continuing to require ICU
support. Satisfying both the FiO\textsubscript{2} and PEEP criteria is
equally important when considering tracheotomy in COVID-19 patients
failing trial(s) of extubation. The case of patient D illustrates why
consideration of FiO\textsubscript{2} requirements alone is not adequate
when it comes to COVID-19 patients. Even if pre-operative
FiO\textsubscript{2} requirements remain below the 50\% cut off,
COVID-19 patients are unlikely to do well following tracheotomy if their
PEEP requirements exceed 8cm H\textsubscript{2}O. The reason is that the
high PEEP dependence makes them less able to tolerate the combination of
a reduction in FiO\textsubscript{2} to 21\% during tracheal exposure and
the subsequent cessation of ventilation prior to tube exchange, both key
recommendation for tracheotomy in COVID-19 patients.\textsuperscript{12}

Furthermore, we have demonstrated that there is a correlation (\selectlanguage{greek}ρ\selectlanguage{english}=0.
955,\emph{p} \textless{}0.05) between the proportion of time patients'
PEEP values are [?]8cm H\textsubscript{2}O and their
FiO\textsubscript{2}values are [?]50\% in the first 48 hours following
tracheotomy with the respective values (ventilation requirements) across
all days of their stay in critical care. This is of clinical importance
because it could potentially permit prognostication through early
risk-stratification; with those patients whose ventilator requirements
consistently remain below the described cut off values (i.e.
FiO\textsubscript{2}[?]50\% and PEEP[?]8cm of H\textsubscript{2}O) for the
first 2 post-operative days to represent a subgroup that can potentially
be safely stepped down to another clinical area outside the ICU
environment at that stage. This has the potential of freeing up
intensive care beds as early as day 2 post-tracheotomy for other
patients that need it more. Furthermore, with the emergence of field
hospitals to help cope with the increased patient demand from the
COVID-19 pandemic, this could assist in identifying those patients who
following tracheotomy are suitable for transfer to such facilities,
further enhancing ICU capacity, a precious and limited resource in the
fight against COVID-19.

Prior to concluding, it is important to consider the strengths and
limitations of this study. The key limitation relates to the small
number of patients (n=12). Another relates to the novelty of the disease
studied meaning that it is likely that further refinements to the
proposed criteria will be needed in the future as our understanding of
the pathophysiology of COVID-19 evolves. Finally, only two prognostic
parameters were studied. Despite these limitations, this study also
features a number of key strengths. It is the first to look into the
development of formal selection criteria for tracheotomy in ventilated
patients with COVID-19 and the first to determine early prognostic
factors for these patients. Moreover, this has been done in a
quantitative manner. By providing actual cut off values for pre- and
post-tracheotomy ventilatory requirements, it facilitates patient
selection, permits risk stratification and in doing so can directly
assist clinical decision-making and inform policy.

In conclusion, this study presents for the first time measurable patient
selection criteria for tracheotomy in COVID-19 patients, illustrating
that an FiO\textsubscript{2}[?]50 \% and PEEP[?]8cm H\textsubscript{2}0 in
the 24 hours prior to tracheotomy are useful markers in helping to
identify those patients that are most likely to benefit from a
tracheotomy. It has also shown that patients that are able to remain
below these threshold values in the first 48 hours following tracheotomy
are likely to exhibit a favourable outcome and can thus be stepped down
from an intensive care setting at that (early) stage, freeing up vital
capacity for other critically ill COVID-19 patients in need of urgent
ICU care.

Bibliography

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9. David AP, Russell MD, El\selectlanguage{english}-Sayed IH, Russell MS. Tracheostomy
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11. To KK-W, Tsang OT-Y, Leung W-S, et al. Temporal profiles of viral
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