Abstract
Background:
Endoscopic percutaneous tracheostomy (PT) is a safe technique that is performed frequently by otolaryngologists and intensivists. New challenges have been identified in order to maintain the safety of this procedure during the COVID-19 pandemic. A novel approach, using a modified demistifier canopy, was developed during the first wave of the pandemic and implemented for 17 consecutive percutaneous tracheostomies in order to enhance procedural safety.
Methods:
A protocol was developed after performing a literature review of tracheostomy in COVID-19 patients. A multidisciplinary tracheostomy team was established, including the departments of otolaryngology, critical care, and respiratory therapy. Simulation was performed prior to each PT, and postoperative debriefings were done.
Results:
A protocol and technical description of PT using a modified demistifier canopy covering was written and video documented. Data were collected on 17 patients who underwent this procedure safely in our tertiary care hospital. There were no procedure-related complications, and no evidence of COVID-19 transmission to any member of the health care team during the study period.
Conclusion:
As patients continue to recover from COVID-19, their need for tracheostomy will increase. The technique described provides a safe, multidisciplinary method of performing PT in COVID-19 patients.
Introduction
In January 2020, COVID-19 was introduced to the world stage, becoming a pandemic in just over 2 short months. By the nature of their work, otolaryngologists were considered at high risk for exposure to respiratory pathogens. Since then, almost all “routine” otolaryngologic procedures have seemingly overnight become high-risk procedures, with tracheostomy being at the top of the list. This has led to an effort by a number of individuals, groups, taskforces, and societies to establish COVID-19-related tracheostomy guidelines pertaining to indications, technique, and safety precautions. The fact that there is no precedent to rely on, except perhaps experience with the related 2003 SARS-CoV epidemic, 1 has made this task difficult and led to inconsistencies from one set of guidelines to the next.
Differences of opinion begin with the indications for tracheostomy in COVID-19 positive patients. Various publications ranged in their opinion of whether or not to perform tracheostomies at all in this patient population.1-5 A large proportion of groups advocated against it entirely and recommended waiting until patients converted to a negative status. The difficulty with this approach is that some infected patients requiring mechanical ventilation may remain positive for up to 6 weeks. Leaving patients intubated for these periods of time is associated with several undesirable short- and long-term sequelae including nosocomial pneumonia, tracheal stenosis, and tracheomalacia. 6 In addition, prolonged intubation delays weaning, thereby prolonging intensive care unit (ICU) stay and reducing ICU bed and ventilator availability.
If tracheostomy is deemed necessary, differences also exist as to how and where the procedure should be performed. Some guidelines suggest an open surgical technique performed in the operating room or at the bedside in a negative pressure room. Certain protocols propose taking these patients to the operating room to ensure a higher degree of safety, while others suggest that the ventilation manipulation required for transporting patients actually increases the risk of exposure to viral particles. To reduce aerosolization, several measures have been suggested by the Canadian and American Societies of Otolaryngology–Head and Neck Surgery. These include doing the procedure with full paralysis, and when entering the trachea, advancing the endotracheal tube (ETT) beyond the tracheal entry point, and temporarily ceasing ventilation. However, even with these precautions, aerosols may also be produced when using cautery or suction during soft tissue dissection to expose the trachea. Furthermore, these patients could be considered as difficult or complicated tracheostomies, given the lack of respiratory reserve in these patients, and the strict infection control measures, personal protective equipment (PPE) required, and psychological pressure on the operating team. 7
Another controversial issue between international guidelines revolves around the timing of tracheostomy in COVID-19 positive ventilator-dependent patients. A systematic review looking at 13 international guidelines found that European guidelines were more likely to propose a more aggressive approach (early tracheostomy) whereas North American, Singaporean, and South-African guidelines propose a more conservative approach.5,8-25 This included waiting for at least 14 days of ventilation or a COVID-19 negative test before any elective tracheostomy. Moreover, none of the guidelines discuss or differentiate specifically why a tracheostomy might be indicated in COVID-19 patients.
Controversy also exists regarding the use of percutaneous tracheostomy (PT) in intubated COVID-19 positive patients, with some guidelines advocating for, or against the procedure. Principle concerns cite the risk of aerosolization from bronchoscopy and dilatation.
Lastly, all guidelines advocate for appropriate PPE use including, but not limited to, N95 or N99 (USA), FFP2 or FFP3 (Europe) mask, the use of double gloves, goggles or eye protection, face shield, and an apron or gown. However, none mention the use of covers or tents to help contain aerosols within a confined space away from the surgeon and other team members.
Over the past year, we have watched ICUs across our province fill with critically ill COVID-19 positive patients requiring mechanical ventilation for weeks at a time. In parallel, consultations for tracheostomy have increased. This served as a powerful incentive to develop a way of performing tracheostomy while protecting the involved personnel. The percutaneous route was chosen because of extensive experience with the technique at our institution alongside other inherent advantages of PT, including the feasibility of performing at the bedside, the reduced time in performing the procedure, and negating the need for an operating room.
In light of these challenges, we present a unique modification of the PT procedure, to allow its safe use in COVID-19 patients. The purpose of this report is to demonstrate the feasibility and safety of our novel method for other otolaryngologist and/or intensivists who routinely perform tracheotomies in the COVID-19 era.
Methods
A literature review on tracheostomies during COVID-19 was performed with a focus on indications, safety precautions, and technique. Search terms used included trach, tracheostomy, tracheotomy, PT, COVID-19, SARS-CoV-2, and coronavirus. After understanding the guidelines from around the world, multidisciplinary meetings and simulations were held at a tertiary care center to discuss available data from the literature and to gain expert recommendations for the safe performance of tracheostomies during the COVID-19 pandemic. Specialists involved included otolaryngologists, intensivists, respiratory therapists, and nurses.
As a result, a novel method to create a safe surgical environment by covering the surgical field with a modified demistifier canopy was created. A demistifier canopy is essentially a large, clear canopy that is often used in the treatment of patients with respiratory syncytial virus (RSV) infection. It is readily available, inexpensive, and simple to modify and install.
A specialized tracheostomy team was mobilized, consisting of a surgeon, a critical care physician, 2 respiratory therapists, 3 senior residents, and experienced ICU nurses. The purpose of this specialized trach team was to create expertise, familiarity, and routine to the procedure. After several meetings to discuss optimal safety processes, a consensus of the methodology was agreed upon by all participants of the specialized tracheostomy team.
After planning the details of the intervention, a multidisciplinary simulation was performed 2 days prior to the first PT, where every step was practiced multiple times, and every individual’s role was defined. This included making a list of required equipment, selecting, testing, and modifying the appropriate material, positioning of all health care workers in the room, practicing bronchoscope placement and timing of ventilation cessation during the procedure to reduce risk of aerosolization. After every simulation followed a thorough debriefing in the presence of all disciplines involved including one external observer. Modifications were made based on each debriefing and a final protocol was created. Here, we describe our experience using this novel method for PT on 3 patients at our institution. Detailed consent was obtained from each patient’s family to perform and document the interventions.
After performing percutaneous tracheotomies in the ICU between the months of April 2020 and January 2021, data were collected retrospectively on 17 patients who underwent this modified procedure. Data were collected on patient characteristics including age, sex, comorbidities, the date of their first COVID-19 positive test, the reason for intubation, the length of intubation prior to tracheostomy, the length of tracheostomy prior to decannulation, and outcome status. This study was approved by the McGill University Health Center Research Ethics Board in August 2020.
Results
Tracheostomy With Demistifier Canopy
Procedural guidelines were developed and can be found in Figure 1. A step-by-step video is also included with the online version of this article. All procedures were performed in a negative pressure room. All personnel wore appropriate PPE, which included an N95 mask or equivalent, a surgical hat with neck cover, a fullface shield, a fluid-repelling gown, and 2 pairs of gloves. All personnel were experienced in donning/doffing procedures. There were no complications following the percutaneous tracheostomies.
List of steps percutaneous tracheostomy in COVID-19 patients. Refer to video for more details.
Patient Outcomes
Data were collected on 17 patients who underwent a PT using the demistifier canopy technique in the ICU between the months of April 2020 and January 2021 (Table 1). The average age was 67.8, with 12 (71%) of patients being male. Fourteen of the patients had a positive COVID-19 test, all of whom were intubated for hypoxic respiratory failure secondary to COVID-19 infection. The other 3 patients were intubated for aspiration pneumonia, severe aortic insufficiency, and cardiac arrest. The average intubation length prior to tracheostomy was 25.2 days, and the average duration of tracheostomy prior to decannulation was 30.3 days. A total of 10 patients were decannulated successfully, with 7 of these fully recovered and discharged from hospital at the time of chart review. Four mortalities occurred (3 from severe respiratory failure and family decision to withdraw care, and 1 from sepsis). Three patients were still admitted to the ICU requiring ongoing ventilator support. Lastly, no members of the specialized tracheostomy team nor the assistants in performing these procedures became infected with COVID-19 throughout the study period. Several members of the team underwent testing with nasopharyngeal swabs at various time points including the respiratory therapists, the primary author, and senior author, all of which were negative at the end of the study period.
Patient Characteristics.
Abbreviations: AF, atrial fibrillation; AI, aortic insufficiency; AVR, aortic valve repair; BPH, benign prostatic hypertrophy; CAD, coronary artery disease; CKD, chronic kidney disease; CVA, cerebrovascular accident; DLP, dyslipidemia; DM 2, type 2 diabetes; HIV, human immunodeficiency virus; HTN, hypertension; IBM, inclusion body myositis; ICU, intensive care unit; ILD, interstitial lung disease; MGUS, monoclonal gammopathy of undetermined significance; MM, multiple myeloma; OSA, obstructive sleep apnea; RAS, renal artery stenosis.
Discussion
As our understanding of COVID-19 improves and survival rates increase, a significant number of patients will be requiring tracheostomy. 3 Tracheostomy offers a number of advantages over endotracheal intubation, including the possibility of weaning off the ventilator as well as diminished sedation requirements. 1 Several recommendations have been put forth in order to minimize the risk to health care professionals performing the tracheostomy.1,4-8,26–30 After gathering information from various otolaryngology, critical care, infectious disease, and anesthesiology societies worldwide, a safe protocol for PT in the ICU was developed.
Percutaneous Versus Open Tracheostomy
Currently, no consensus has been reached worldwide on which technique, percutaneous versus open, is preferable in COVID-19 positive patients. For the time being, the French and Spanish Societies of Otolaryngology recommend PT, the Italian recommend open, and the American and United Kingdom societies do not specify a preferred approach. 1 The Canadian Society recommends an open technique, although the provinces of Quebec and Manitoba are performing both percutaneous and open approaches. The difficulty in reaching a consensus revolves around the very legitimate concern of virus aerosolization.
Percutaneous tracheostomy was selected as the preferred method in this study. At our tertiary care institution, PT is performed by the Otolaryngology service exclusively and was the method of choice due to extensive familiarity and experience with the procedure. Several reports have demonstrated equivalent outcomes and safety of PT compared to open.26,31,32 Several advantages were identified that favored the percutaneous route. The procedure is performed at the bedside, obviating the need for transportation to the operating room. Mishaps during transport, such as accidental extubation, can be a life-threatening event for the patient, while simultaneously placing the personnel performing the reintubation at risk. Furthermore, PT does not require cautery, or suction, 1 thereby eliminating the aerosol risk from these devices. Finally, a recent publication reports on 98 patients with COVID-19-associated pneumonia who underwent PT in New York City. 33 Their technique involved passing the bronchoscope around the ETT rather than through it. No members of their team became infected.
Demistifier Canopy Use
A recent study by Chow et al placed a clear plastic drape over their surgical field during 5 consecutive open tracheostomies in COVID-19 negative patients. 34 They subsequently measured droplet counts on the plastic sheet, as well as the face shields worn by the surgeon and scrub nurse. They found droplet contamination on all 5 plastics drape sheets, despite meticulous dissection and hemostasis in uncomplicated surgeries. No droplets were found on all face shields however, indicating that the use of overlying plastic drapes can add a protective barrier for health workers.
The demistifier canopy is traditionally used for medication administration in RSV positive patients. It is pliable, inexpensive, readily available and easy to modify. It comes with 4 integrated elastic bands at its surface, allowing it to be easily attached to 4 adjustable IV poles around the patient’s bed. The demistifier canopy is prepared prior to entering the room. It covers the head and chest of the patient completely, including the ETT. All entry points for hands are identified before the procedure, allowing for a smooth sequence of events. Cutting out a surgical glove, which overlies the entry site for each hand, provides enhanced protection by creating a tight seal around the arms.
All participants involved in the use of the demistifier canopy felt very comfortable with the procedure after 1 to 2 simulations and debriefing sessions prior to performing the tracheostomy in the ICU. This included the nursing team, respiratory therapists, otolaryngologists, and intensivists who were directly involved with the procedure. Disadvantages to using the canopy included slight limitations in visualization through the material of the canopy; however, given that PT is performed principally by palpation of the anatomy more than direct visualization, all operating surgeons felt comfortable throughout the procedure including staff physicians and senior residents. As the bronchoscopy tower was outside of the canopy, visualization of the airway and endoscopic view of the procedure was always clear. Nursing staff and respiratory therapists involved in the procedures also felt comfortable with the added safety of the canopy.
Cessations in Ventilation
Cessation of ventilation is an important part of the sequence of events to maximize safety. The first cessation of ventilation occurs during the insertion of the bronchoscope into the ETT adapter. Ventilation is not restarted until the tube and bronchoscope are in proper position with the cuff inflated. In our experience, this step takes 30 seconds. The second cessation in ventilation occurs when the trachea is punctured and persists until the tracheostomy is inserted, the cuff is inflated, and the circuit is connected to the trachea. In all 3 trials with the demistifier canopy, the time from insertion of the first needle to the tracheostomy insertion required a single cessation of ventilation, lasting between 45 and 90 seconds, without any desaturations. This precaution should theoretically lead to almost no aerosol generation.
Minimal Personnel
As mentioned above, the current protocol allows for minimal personnel presence during the tracheostomy, including 1 surgeon, 1 bronchoscopist, 1 respiratory therapist, and 1 nurse. This is possible because of advance preparation through simulation with all team members present. This is critical and ensures that the procedure runs quickly and smoothly. Identifying a dedicated team of experienced individuals is recommended. This creates expertise, proficiency in the technique and a calm, organized sequence of steps. Having the forearm of one bronchoscopist and one respiratory therapist in the tent allows for easy manipulation of the ETT and bronchoscope while looking above the tent at a screen, away from the patient. A cotton tracheal tie increases the ease of tube withdrawal. Double adapters on the ETT allowed for easy disconnection of the circuit from the ETT to the tracheostomy. Extensions on intravenous lines allow the nurse to be positioned 2 to 3 meters from the bed for increased safety.
Timing
Recommendations by the American Academy of Otolaryngology–Head and Neck Surgery state that patients should remain intubated for at least 3 weeks or more prior to tracheostomy. 6 This is in large part due to recommendations from a number of organizations and guidelines advocating for delayed tracheostomy because of legitimate safety concerns. We believe this modified PT technique provides superior safety and will allow us to intervene in a timelier manner in intubated COVID-19 positive patients.
Limitations
Limitations to this study include the small number of participants, although no patient or participant complications were encountered by the use of this technique. Furthermore, other centers may not have the volume, expertise, or comfort in performing percutaneous tracheostomies at bedside which is a prerequisite for this modified technique. Further work needs to be done before this technique can be universally adopted.
Conclusion
The COVID-19 pandemic has changed our approach to tracheostomy. We have a responsibility to provide good care to our patients while keeping ourselves safe. We believe this modified PT technique meets these requirements, although further experience is necessary prior to its widespread and universal use.
Footnotes
Authors’ Note
K.K. is senior author. All materials generated during this study are included in this published article. All authors contributed equally. This study was approved by the McGill University Health Center Research Ethics Board in August 2020.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
