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\begin{document}

\title{Safe~ and effective management of Tracheostomy~ in COVID-19 patients}



\author[1]{Hongjun Xiao,MD}%
\affil[1]{Union Hospital, Tongji Medical College}%


\vspace{-1em}



  
  \date{May 23, 2024}


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\selectlanguage{english}
\begin{abstract}
Background: An increasing number of COVID-19 patients worldwide will
probably need tracheostomy in an emergency or at the recovering stage of
COVID-19. We explored the safe and effective management of tracheostomy
in COVID-19 patients, to benefit patients and protect healthcare workers
at the same time.

Methods: We retrospectively analyzed 11 hospitalized COVID-19 patients
undergoing tracheostomy. Clinical features of patients, ventilator
withdrawal after tracheostomy, surgical complications and nosocomial
infection of the healthcare workers associated with the tracheostomy
were analyzed.

Results: All the tracheostomy of 11 cases (100\%) were performed
successfully, including percutaneous tracheostomy of 6 cases (54.5\%)
and conventional open tracheostomy of 5 cases (45.5\%). No severe
postoperative complications occurred, and no healthcare workers
associated with the tracheostomy are confirmed to be infected by
SARS-CoV-2.

~Conclusion: Comprehensive evaluation before tracheostomy, optimized
procedures during tracheostomy, and special care after tracheostomy can
make the tracheostomy safe and beneficial in COVID-19 patients.%
\end{abstract}%



\sloppy


Xiaomeng Zhang\textsuperscript{1}, MD; Qiling Huang\textsuperscript{1},
MD; Xun Niu, MD\textsuperscript{1}; Tao Zhou\textsuperscript{1}, MD;
Zhen Xie\textsuperscript{1}, MD; Yi Zhong\textsuperscript{1}, MD;
Hongjun Xiao\textsuperscript{1}, MD

\textsuperscript{1}Department of Otorhinolaryngology, Union Hospital,
Tongji Medical College, Huazhong University of Science and Technology,
Wuhan, China

~\textbf{Correspondence:}

Hongjun Xiao, Department of Otorhinolaryngology, Union Hospital, Tongji
Medical College, Huazhong University of Science and Technology, 1277
Jiefang Ave, 430022, Wuhan, China.

Email: {xhjent@163.com}

~

Yi Zhong, Department of Otorhinolaryngology, Union Hospital, Tongji
Medical College, Huazhong University of Science and Technology, 1277
Jiefang Ave, 430022, Wuhan, China.

Email: zyzy0411@163.com

~

These authors contributed equally: Xiaomeng Zhang and Qiling Huang.

~

\textbf{Abstract}

\textbf{Background:} An increasing number of COVID-19 patients worldwide
will probably need tracheostomy in an emergency or at the recovering
stage of COVID-19. We explored the safe and effective management of
tracheostomy in COVID-19 patients, to benefit patients and protect
healthcare workers at the same time.

\textbf{Methods:} We retrospectively analyzed 11 hospitalized COVID-19
patients undergoing tracheostomy. Clinical features of patients,
ventilator withdrawal after tracheostomy, surgical complications and
nosocomial infection of the healthcare workers associated with the
tracheostomy were analyzed.

\textbf{Results:} All the tracheostomy of 11 cases (100\%) were
performed successfully, including percutaneous tracheostomy of 6 cases
(54.5\%) and conventional open tracheostomy of 5 cases (45.5\%). No
severe postoperative complications occurred, and no healthcare workers
associated with the tracheostomy are confirmed to be infected by
SARS-CoV-2.

~\textbf{Conclusion:} Comprehensive evaluation before tracheostomy,
optimized procedures during tracheostomy, and special care after
tracheostomy can make the tracheostomy safe and beneficial in COVID-19
patients.

~

\textbf{1. INTRODUCTION}

Beginning in December 2019, a novel coronavirus (SARS-CoV-2), has caused
an international outbreak of acute respiratory illness termed
COVID-19\textsuperscript{1-3}. Up to April 26, 2020, more than 2,943,000
infections and 204,000 deaths are reported in worldwide. So far, there
are no specific therapeutic agents for the treatment of COVID-19. For
some hospitalized patients with severe COVID-19, endotracheal intubation
and mechanical ventilation is a common and indispensable life-saving
treatment\textsuperscript{4-5}.

In COVID-19 patients with long-term endotracheal intubation and
mechanical ventilation, tracheotomy may be
considered\textsuperscript{6-7}. However, many clinicians think
tracheotomy should be avoided if at all possible, because the risk
arises not only during the procedure but also during the process of the
care for the patients afterwards. Therefore, tracheotomy has become
known as one of the most high-risk surgical procedures in patients with
Covid-19. Usually percutaneous dilational tracheotomy is preferred to be
used, which is a minimally invasive method that can be performed at the
bedside\textsuperscript{8}. But some patients with unfavorable neck
anatomy, including short neck, enlarged thyroid, neck cicatricial
contracture and so on, are not considered to be suitable for
percutaneous tracheotomy. In these circumstances, conventional
tracheotomy is an inevitable choice for surgeons who perform
tracheotomy. During conventional open tracheotomy, the opening of the
airway is more prone to cause secretion spatter which is
aerosol-generating and may contribute to nosocomial spread of viruses
from patients to operating room personnel. The SARS-CoV-2 virus from
patients can remain viable and infectious in aerosols for hours and on
surfaces up to days\textsuperscript{9}, paving the way for nosocomial
spread. Therefore, whether the COVID-19 patients need to undergo
tracheotomy and how to avoid nosocomial spread during tracheostomy or
after tracheostomy is crucial to benefit the patients and prevent
healthcare workers from the risk of transmission of coronavirus.

In the past three months, our team in Wuhan Union Hospital (West
Branch), which was a designated key hospital for severe Covid-19
patients in Wuhan, China, developed experience in treating Covid-19
patients, including various drug-treatments and tracheostomy. The number
of patients with laboratory-confirmed SARS-CoV-2 infection continues to
grow as many countries involved. In the following months, an increasing
number of Covid-19 patients worldwide will probably need long-term
endotracheal intubation and possibly even tracheotomy. Here, we report
the clinical characteristics of COVID-19 patients with tracheostomy and
management of tracheostomy in COVID-19 patients in our hospitals, which
are located in the epicenter of China.

~

\textbf{2.} \textbf{PATIENTS AND METHODS}

\textbf{2.1 Study design}

This retrospective, observational study was done at the designated
special care center for severe COVID-19 patients of Union Hospital (West
Branch) of Huazhong University of Science and Technology (Wuhan, China).
This center is one of the designated hospitals assigned by the
government to treat patients with COVID-19. We retrospectively analyzed
consecutive hospitalized patients from January 23, 2020, to April 6,
2020, who had been diagnosed as having COVID-19. A case of COVID-19 was
confirmed by a positive result of SARS-CoV-2 infection on highthroughput
sequencing or real-time reverse-transcription polymerase chain reaction
analysis of throat swab specimens. A total of 1361 hospitalized patients
with laboratory confirmation of SARS-CoV-2 infection were identified in
this center. Of these, 11 medical records were available for review.
Cases were screened for those performed by a tracheostomy, including
percutaneous tracheostomy performed by intensive care doctors, and
conventional open tracheostomy performed by otolaryngologists from our
team. Indications for surgery, surgical complications and adjuvant
therapy were identified from the patient's clinical records. This study
was approved and written informed consent was waived by the Ethics
Committee of Union hospital, owing to the rapid emergence of the disease
and the urgent need to collect data. At the time of treatment, extensive
discussion was conducted with the patient or a relative for patients who
could not give consent, describing the risks and benefits of surgery.

~\textbf{2.2 Data Collection}

We reviewed electronic medical records, nursing records, and laboratory
findings for all COVID-19 patients undergoing tracheotomy and collected
data. The baseline characteristics contained demographic, comorbidities,
endotracheal intubation, laboratory parameters, therapy history,
bacterial biology of sputum, types of tracheostomy and ventilator
withdrawal. Comorbidities consisted of hypertension, diabetes, cardiac
or cerebrovascular disease, and malignancy. Therapy history referred to
anticoagulant therapy and transfusion therapy. Laboratory parameters
were collected on the basis of venous blood samples. Intervention
referred to the type of tracheostomy and ventilator withdrawal
conducted. Surgical complications associated with tracheostomy were also
analyzed. The surgical complications contained death, postoperative
bleeding, wound infection, subcutaneous emphysema, pneumothorax and
mediastinal emphysema, respiratory arrest, cannula prolapse, and
tracheoesophageal fistula. We defined the degree of severity of COVID-19
(severe vs nonsevere) at the time of admission using the American
Thoracic Society guidelines for community-acquired
pneumonia\textsuperscript{10}.

~

\textbf{2.3 Analysis}

For baseline data, mean and rang range for data that were not normally
distributed. Categorical variables were expressed as counts and
percentages.

~

\textbf{3. RESULTS}

Of 1361 patients with confirmed SARS-CoV-2 infection, 247 patients
(18.1.0\%) had non severe infection and 1114 patients (81.9\%) had
severe infection according to their respiratory status. Overall, 11
patients (0.8\%) with tracheostomy were included in the analysis. All of
them were elective tracheostomy, including percutaneous tracheostomy
which was preferred and conventional open tracheostomy for patients with
difficult airway. Their demographic and clinical characteristics were
shown in Table 1. Their mean (rang) age was 66.2 (32 - 93) years, and 7
(63.6\%) were male. Of these patients, 9 (81.2\%) had at least 1 of the
following comorbidities: hypertension (8 {[}72.3\%{]}), diabetes (2
{[}18.2\%{]}), cardiac or cerebrovascular disease (4 {[}36.4\%{]}), and
malignancy (1 {[}9.1\%{]}). Of these 11 patients with tracheostomy, 11
patients (100\%) had at least 1 of the following underlying disorders:
Coagulation function abnormity (10 {[}90.9\%{]}), including D-dimer
abnormity (10 {[}90.9\%{]}) and APTT abnormity (4 {[}36.4\%{]}), anaemia
(9 {[}81.8\%{]}), thrombocytopenia (5 {[}45.5\%{]}); liver function
abnormity (5 {[}45.5\%{]}); renal function abnormity (4 {[}36.4\%{]}).

All of these patients with tracheostomy were severe COVID-19 patients
which previously received endotracheal intubation and mechanical
ventilation. Before tracheostomy, the mean (range) hospitalization day
was 26.6 (6, 58) days, and the mean (range) duration of intubation was
16.8 (6, 36) days. Only 1 patient with cerebral hemorrhage was performed
percutaneous tracheostomy 6 days after the brain surgery and
endotracheal intubation, while the other 10 patients were performed
tracheostomy at least 12 days after endotracheal intubation. Of 11
patients with tracheostomy, 10 patients (90.9\%) received anticoagulant
therapy and 6 patients (54.5\%) received transfusion therapy before
tracheostomy, to correct the coagulation disorders. Of these patients,
bacterial biology of sputum before tracheostomy demonstrated that 11
patients (100\%) had at least 1 infection of the following bacteria:
Klebsiella pneumoniae (5 {[}45.5\%{]}), Acinetobacter baumannii (7
{[}63.6\%{]}), Pseudomonas aeruginosa (4 {[}36.4\%{]}), and
Stenotrophomonas maltophilia (5 {[}45.5\%{]}).

Finally, after tracheostomy, 9 patients (81.8\%) acquired ventilator
withdrawal, and the mean (range) duration of intubation after
tracheostomy was 6.9 (2, 19) days. In patients with percutaneous
tracheostomy, the mean (range) duration of intubation between
tracheostomy and ventilator withdrawal was 10.4 (4, 19) days. In
patients with conventional open tracheostomy, the mean (range) duration
of intubation between tracheostomy and ventilator withdrawal was 2.5 (2,
4) days.

Table 2 showed the surgical complications during the tracheostomy or in
the postoperative period. There were no patients with any of the
following complications: death, postoperative bleeding, pneumothorax and
mediastinal emphysema, respiratory arrest, cannula prolapse, and
tracheoesophageal fistula. Of these patients with tracheostomy, 2
(18.2\%) had wound infection, and 1 (9.1\%) had subcutaneous emphysema.
Overall, according to our protocol for the management of tracheostomy
(Figure 1) , both percutaneous tracheostomy and conventional open
tracheostomy were safe for patients, if health workers performed
adequate preoperative evaluation and preparation, and good surgery
operation.

Moreover, no healthcare workers associated with the tracheostomy are
confirmed to be infected by SARS-CoV-2, after 14 days out of working
environment. All the conventional open tracheostomy were performed by
doctors from otorhinolaryngology (Figure 2A and 2B) according to the
method described in our previous paper\textsuperscript{11}, and the
percutaneous tracheostomy were performed by doctors from intensive care
unit according to the standard method. Patients' care were performed by
nurses from intensive care unit and otorhinolaryngology. In addition to
personal protective equipment \textbf{(}PPE), heal and moisture
exchanger (HME) united closed tracheal suction catheters were strongly
recommended to use in care for patients with tracheostomy or
endotracheal intubation (Figure 2C and 2D), in order to avoid secretion
splashing. According to our protocol of tracheostomy and nursing (Figure
3), all of the doctors and nurses, including anesthesiologists for
tracheostomy and nurses in the operation room, are safe during the
tracheostomy or in the postoperative period.

\textbf{4. DISCUSSION}

To our knowledge, this is the first report on the demographic and
clinical characteristics of COVID-19 patients with tracheostomy in the
epicenter of China. As of April 6, 2020, 1361 patients with confirmed
SARS-CoV-2 infection were hospitalized in our hospital (West Branch),
including 1114 patients (81.9\%) with severe infection according to
their respiratory status, and 11 patients (0.8\%) with tracheostomy were
included in the analysis. All of the tracheostomies were elective
tracheostomy, including two types of tracheostomy: percutaneous
tracheostomy (6 cases) and conventional open tracheostomy (5 cases). In
tracheotomy and postoperative period, splashing of airway secretions
caused by open airway-related wound, cough reflex and ventilator
ventilation may lead to the direct splashing of virus-carrying
secretions to medical personnel and massive formation of aerosol in
surgical environment, thus greatly increasing the risk of nosocomial
dissemination. Therefore, in addition to the safety of patients, the
important issue of the tracheotomy is to protect the healthcare workers
and the surgical environment to avoid nosocomial infection.

For patients with severe COVID-19, endotracheal intubation and
mechanical ventilation are important treatments to maintain their vital
signs. However, if prolonged endotracheal intubation can not effectively
facilitate the discharge of sputum, and this situation may seriously
affected the airway patency of the patient and ventilator withdrawal,
and then tracheotomy should be considered. However, for elective
tracheotomy, intensivists, anesthesiologists, and otolaryngologists
should conduct a comprehensive pre-surgery assessment to select the
appropriate point in time and type of tracheotomy. Whether early
tracheotomy after mechanical ventilation with intubation could
facilitate the early withdrawal of ventilator is still a controversial
issue\textsuperscript{12-13}. However, there is a consensus among all
disciplines that the removal of endotracheal intubation can increase the
comfort of patients, reduce respiratory dead space and work of
breathing, and reduce the use of sedatives which is helpful for reviving
patients and restoring the cough reflex\textsuperscript{13}. Therefore,
with comprehensive multidisciplinary assessment, elective tracheotomy
may be generally considered when extubation can not be performed after
more than 7 days of endotracheal~ intubation, or in a short period of
time.

Usually, percutaneous tracheotomy is preferred8, which is a minimally
invasive surgical method with the advantages of less
time-consuming\textsuperscript{14}, less splashing and being a bedside
operation\textsuperscript{15}. However, some patients are not suitable
for percutaneous tracheotomy because of possible difficulties in
exposure of cervical trachea (e.g. humpback, short neck, obesity,
enlarged thyroid, neck cicatricial contracture, et al.). At this
situation, conventional open tracheostomy is an inevitable choice. But
many doctor may think it is much more dangerous than percutaneous
tracheotomy, and possibly influence the choice of tracheostomy under the
background of COVID-19 pandemic. However, according to our optimized
protocol for conventional open tracheostomy\textsuperscript{11}, this is
about to be reversed. As shown in Figure 3, the operators performed
conventional open tracheostomy under general anesthesia with application
of muscle relaxants, in order to completely avoid the cough reflex of
patients during surgery. And the anesthesiologists help to move the
endotracheal tube (ETT) close to carina of the trachea and this action
can make the ETT cuff deeper than the incision site to prevent the ETT
cuff leak due to an accidental damage to the cuff when making the
tracheal opening. And when making the tracheal opening, a brief pause
for ventilator is conducted. In a word, it's all about constantly
keeping the lung, trachea and ventilator as an enclosed environment
before making incision on the cervical trachea. Therefore, the safety of
healthcare workers can be achieved during conventional open
tracheostomy.

For each candidate of tracheostomy, adequate preoperative evaluations
were needed. First, it is essential to acquire the anesthesiologist
assessment for possibility and safety of general anesthesia, especially
in conventional open tracheostomy. In the condition of general
anesthesia, the use of sedative anesthetic and muscle relaxant can
effectively avoid the cough reflex during tracheotomy. Second,
transfusion therapy for severe coagulation function abnormity,
thrombocytopenia and anaemia, should be considered before tracheotomy.
Of 11 patients with tracheostomy, 10 patients (90.9\%) recieved
anticoagulant therapy because of high D-Dimer levels and 6 patients
(54.5\%) recieved transfusion therapy before tracheostomy. Although we
can not get their coagulation function to the normal level, it is still
necessary to ameliorate the situation for the safety of COVID-19
patients with elective tracheostomy. Of these 11 patients with
tracheostomy, we tried to adjust APTT prolonged time less than 10
seconds, hemoglobin (Hg) content not less than 60 g/L, and platelet
(PLT) count not less than 60 x 10\textsuperscript{12}/L. Of course,
these are not absolute restrictions. In one case with APTT prolonged
time more than 20 seconds, the patient received conventional open
tracheostomy, and no surgical complications occurred, with much more
careful manipulation of operators. Third, it is also important to take
into consideration the impacts of ventilator associated pneumonia
(acterial biology of sputum and the duration of endotracheal intubation,
et al.). Of 11 patients with tracheostomy, the mean (range) duration of
intubation before tracheostomy was 16.8 (6, 36) days, and bacterial
biology of sputum before tracheostomy demonstrated that 11 patients
(100\%) had at least one of pathogenic bacteria of ventilator associated
pneumonia. In this situation, tracheostomy should be considered to be
effective and helpful for the recovery of respiratory diseases.

According to our protocol, comprehensive evaluation and preparation
before tracheostomy, optimized procedures during tracheostomy, and
special care after tracheostomy were utilized. No severe complications
occurred during tracheostomy or postoperative period, and 9 cases
(81.8\%) were evacuated from the ventilator after tracheostomy.
According to our protocol of tracheostomy and nursing, no healthcare
workers associated with the tracheostomy are confirmed to be infected by
SARS-CoV-2. These findings suggested that it was safe and effective to
perform tracheostomy in COVID-19 patients with long-term endotracheal
intubation and mechanical ventilation, if necessary.

In patients with conventional open tracheostomy, the mean (range)
duration of intubation between tracheostomy and ventilator withdrawal
was 2.5 (2, 4) days, which was much shorter than that of percutaneous
tracheostomy (10.4 {[}4, 19{]} days). These results may be due to the
fact that in the early stage of the outbreak of COVID-19, the patients
were often in more severe condition and percutaneous tracheostomy were
preferred, because of concerns about for the safety of healthcare
workers and the stress on medical resources. These severe patients with
percutaneous tracheostomy often needed much more time for recovery. In
late stage of the outbreak of COVID-19, more patients with difficult
airway were considered for conventional open tracheostomy, since more
medical resources can be acquired. Moreover, in the late stage the
outbreak of COVID-19, more patients were also in recovery of the
disease. Therefore, this was not due to the type of tracheostomy.

~

\textbf{5. CONCLUSION}

This study may offer important new clinical information on COVID-19
patients with tracheostomy. It is especially meaningful to learn that
for those patients with severe COVID-19, tracheostomy could be safe and
beneficial for the patients. Comprehensive evaluation before
tracheostomy and optimized procedures during tracheostomy were necessary
and useful. Moreover, during the epidemic period of COVID-19, both
adequate personal protective equipment \textbf{(}PPE) and appropriate
protocols of tracheostomy and nursing are important for the safety of
healthcare workers. Therefore, these protocols should be a good choice
for all surgeons performing the tracheostomy for Covid-19 patients. They
are helpful to rescue severe patients, and at the same time, to protect
healthcare workers from the threat of coronavirus infection.

~

\textbf{ACKNOWLEDGMENTS}

None.

~

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13. Arabi Y, Haddad S, Shirawi N, et al. Early tracheostomy in intensive
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14. Putensen C, Theuerkauf N, Guenther U, et al. Percutaneous and
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Crit Care. 2014;18(6):544.

15. Miles BA, Schiff B, Ganly I, et al. Tracheostomy during
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Society. Head Neck. 2020.

~

\textbf{Figure Legends}

Figure 1 The protocol for preoperative evaluations and choices of
tracheostomy in COVID-19 patients.

~\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-1-(2)/Figure-1-(2)}
\caption{{This is a caption
{\label{658603}}%
}}
\end{center}
\end{figure}

Figure 2 The medical management and protection of of healthcare workers
associated with the tracheostomy.

(A) The surgery team from otorhinolaryngology was performing
conventional open tracheostomy.

(B) The personal protective equipment \textbf{(}PPE) for one member from
the surgery team.

(C) Closed tracheal suction catheters were used in care for COVID-19
patients.

(D) The nurse was performing airway nursing for COVID-19 patients.

~\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure2--(1)/Figure2--(1)}
\caption{{This is a caption
{\label{756293}}%
}}
\end{center}
\end{figure}

Figure 3 The three shields of healthcare workers in tracheostomy and
nursing for COVID-19 patients.\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-3--(1)/Figure-3--(1)}
\caption{{This is a caption
{\label{548583}}%
}}
\end{center}
\end{figure}



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