TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial.

BACKGROUND: Critically ill COVID-19 patients may develop acute respiratory distress syndrome and the need for respiratory support, including mechanical ventilation in the intensive care unit. Previous observational studies have suggested early tracheotomy to be advantageous. The aim of this parallel, multicentre, single-blinded, randomized controlled trial was to evaluate the optimal timing of tracheotomy. METHODS: SARS-CoV-2-infected patients within the Region Västra Götaland of Sweden who needed intubation and mechanical respiratory support were included and randomly assigned to early tracheotomy (≤ 7 days after intubation) or late tracheotomy (≥ 10 days after intubation). The primary objective was to compare the total number of mechanical ventilation days between the groups. RESULTS: One hundred fifty patients (mean age 65 years, 79% males) were included. Seventy-two patients were assigned to early tracheotomy, and 78 were assigned to late tracheotomy. One hundred two patients (68%) underwent tracheotomy of whom sixty-one underwent tracheotomy according to the protocol. The overall median number of days in mechanical ventilation was 18 (IQR 9; 28), but no significant difference was found between the two treatment regimens in the intention-to-treat analysis (between-group difference: - 1.5 days (95% CI - 5.7 to 2.8); p = 0.5). A significantly reduced number of mechanical ventilation days was found in the early tracheotomy group during the per-protocol analysis (between-group difference: - 8.0 days (95% CI - 13.8 to - 2.27); p = 0.0064). The overall correlation between the timing of tracheotomy and days of mechanical ventilation was significant (Spearman's correlation: 0.39, p < 0.0001). The total death rate during intensive care was 32.7%, but no significant differences were found between the groups regarding survival, complications or adverse events. CONCLUSIONS: The potential superiority of early tracheotomy when compared to late tracheotomy in critically ill patients with COVID-19 was not confirmed by the present randomized controlled trial but is a strategy that should be considered in selected cases where the need for MV for more than 14 days cannot be ruled out. Trial registration NCT04412356 , registered 05/24/2020.

Tracheotomy in the SARS-CoV-2 pandemic.

The severe acute respiratory syndrome (SARS)-CoV-2 pandemic continues to produce a large number of patients with chronic respiratory failure and ventilator dependence. As such, surgeons will be called upon to perform tracheotomy for a subset of these chronically intubated patients. As seen during the SARS and the SARS-CoV-2 outbreaks, aerosol-generating procedures (AGP) have been associated with higher rates of infection of medical personnel and potential acceleration of viral dissemination throughout the medical center. Therefore, a thoughtful approach to tracheotomy (and other AGPs) is imperative and maintaining traditional management norms may be unsuitable or even potentially harmful. We sought to review the existing evidence informing best practices and then develop straightforward guidelines for tracheotomy during the SARS-CoV-2 pandemic. This communication is the product of those efforts and is based on national and international experience with the current SARS-CoV-2 pandemic and the SARS epidemic of 2002/2003.

Tracheostomy for COVID-19 Respiratory Failure: Multidisciplinary, Multicenter Data on Timing, Technique, and Outcomes.

OBJECTIVE: The aim of this study was to assess the outcomes of tracheostomy in patients with COVID-19 respiratory failure. SUMMARY BACKGROUND DATA: Tracheostomy has an essential role in managing COVID-19 patients with respiratory failure who require prolonged mechanical ventilation. However, limited data are available on how tracheostomy affects COVID-19 outcomes, and uncertainty surrounding risk of infectious transmission has led to divergent recommendations and practices. METHODS: It is a multicenter, retrospective study; data were collected on all tracheostomies performed in COVID-19 patients at 7 hospitals in 5 tertiary academic medical systems from February 1, 2020 to September 4, 2020. RESULT: Tracheotomy was performed in 118 patients with median time from intubation to tracheostomy of 22 days (Q1-Q3: 18-25). All tracheostomies were performed employing measures to minimize aerosol generation, 78.0% by percutaneous technique, and 95.8% at bedside in negative pressure rooms. Seventy-eight (66.1%) patients were weaned from the ventilator and 18 (15.3%) patients died from causes unrelated to tracheostomy. No major procedural complications occurred. Early tracheostomy (≤14 days) was associated with decreased ventilator days; median ventilator days (Q1-Q3) among patients weaned from the ventilator in the early, middle and late groups were 21 (21-31), 34 (26.5-42), and 37 (32-41) days, respectively with P = 0.030. Compared to surgical tracheostomy, percutaneous technique was associated with faster weaning for patients weaned off the ventilator [median (Q1-Q3): 34 (29-39) vs 39 (34-51) days, P = 0.038]; decreased ventilator-associated pneumonia (58.7% vs 80.8%, P = 0.039); and among patients who were discharged, shorter intensive care unit duration [median (Q1-Q3): 33 (27-42) vs 47 (33-64) days, P = 0.009]; and shorter hospital length of stay [median (Q1-Q3): 46 (33-59) vs 59.5 (48-80) days, P = 0.001]. CONCLUSION: Early, percutaneous tracheostomy was associated with improved outcomes compared to surgical tracheostomy in a multi-institutional series of ventilated patients with COVID-19.

Is Timing of Tracheotomy a Factor Influencing the Clinical Course in COVID-19 Patients?

The timing of tracheotomy is a complex decision that requires understanding of the relative risks and benefits as compared with prolonging intubation. The role of tracheotomy during the COVID-19 pandemic remains to be determined. There is no evidence that early tracheostomy improves patient's clinical course and it is not impact on the natural history of these patients. In our opinion, the tracheotomy should be proposed in stable COVID-19 patients after 18th days after orotracheal intubation when the viral load is finished. Only in the case of patients with difficult of intubation do we perform earlier tracheotomies.

Comparison of percutaneous dilatational tracheotomy versus open surgical technique in severe COVID-19: Complication rates, relative risks and benefits.

OBJECTIVE: Patients with acute respiratory failure due to COVID-19 have a high likelihood of needing prolonged intubation and may subsequently require tracheotomy. Usually, the choice of technique (percutaneous dilatational tracheotomy [PDT] versus open surgical tracheotomy [OST]) depends on the preference of surgeons and patient-related factors. In case of COVID-19, airborne spread of viral particles and limited time of apnea must be considered in the choice of the safest technique. The aim of this study is to compare the complication rates and offer an assessment of relative risks and benefits of PDT versus OST in patients with severe COVID-19. METHODS: We performed a retrospective study considering 47 consecutive patients affected by severe acute respiratory distress syndrome due to SARS-CoV-2 infection, needing invasive mechanical ventilation and subsequent tracheostomy. This study was performed at the Intensive Care Unit of our tertiary referral center. Complication rates were analyzed. RESULTS: Seventeen patients underwent PDT and 30 patients were submitted to OST. Twenty-six patients (55.3%) had post-operative complications (local infection, hemorrhage, subcutaneous emphysema) with no significant difference between PDT and OST. CONCLUSION: PDT and OST are characterized by similar postoperative complication rates in severe COVID-19 patients. These findings suggest that OST might be preferred if expert ENT surgeons are available, as PDT could result in longer apnea and exposure to generated aerosol. However, authors recommend considering either OST or PDT at the discretion of the medical staff involved, according to the personal experience of the operators performing the procedure.

The Role of Tracheotomy and Timing of Weaning and Decannulation in Patients Affected by Severe COVID-19.

OBJECTIVES: Patients with acute respiratory failure due to coronavirus disease 2019 (COVID-19) have a high likelihood of needing prolonged intubation and may subsequently require tracheotomy. Indications and timing for performing tracheotomy in patients affected by severe COVID-19 pneumonia are still elusive. The aim of this study is to analyze the role of tracheotomy in the context of this pandemic. Moreover, we report the timing of the procedure and the time needed to complete weaning and decannulation in our center. METHODS: This retrospective, observational cohort study included adults (≥18 years) with severe COVID-19 pneumonia who were admitted to the intensive care unit (ICU) of the tertiary care center of Reggio Emilia (Italy). All patients underwent orotracheal intubation with invasive mechanical ventilation, followed by percutaneous or open surgical tracheotomy. Indications, timing of the procedure, and time needed to complete weaning and decannulation were reported. RESULTS: Forty-four patients were included in the analysis. Median time from orotracheal intubation to surgery was 7 (range 2-17) days. Fifteen (34.1%) patients died during the follow-up period (median 22 days, range 8-68) after the intubation. Weaning from the ventilator was first attempted on median 25th day (range 13-43) from orotracheal intubation. A median of 35 (range 18-79) days was required to complete weaning. Median duration of ICU stay was 22 (range 10-67) days. Mean decannulation time was 36 (range 10-77) days from surgery. CONCLUSIONS: Since it is not possible to establish an optimal timing for performing tracheotomy, decision-making should be made on case-by-case basis. It should be adapted to the context of the pandemic, taking into account the availability of intensive care resources, potential risks for health care workers, and benefits for the individual patient.

Safety and efficacy of tracheotomy for critically ill patients with coronavirus disease 2019 (COVID-19) in Wuhan: a case series of 14 patients.

OBJECTIVES: Coronavirus disease 2019 (COVID-19) is a global pandemic. Critically ill patients often require prolonged intubation for mechanical ventilation to support breathing; thus, the artificial airway must be managed by tracheotomy. Therefore, studies exploring appropriate and safe methods for tracheotomy that minimize the risks of nosocomial transmission are important. METHODS: A retrospective analysis of the clinical characteristics of 14 critically ill patients with COVID-19, who underwent bedside tracheotomy from March to April 2020 was conducted to summarize the indications for tracheotomy and key points related to personal protective equipment and surgical procedures. RESULTS: All 14 patients were diagnosed with COVID-19 and were critically ill. All tracheotomies were performed in the late phase of the infection course. The interval between the infection and tracheotomy was 33 days, and the median interval between intubation and tracheotomy was 25.5 days. The reverse transcription-polymerase chain reaction results of secretions from the operative incision and inside the tracheotomy tube were negative. Twelve patients improved after tracheotomy, with SpO2 levels maintained above 96%. One patient died of progressive respiratory failure; another patient died of uncontrolled septic shock. No medical staff who participated in the tracheotomy was infected. CONCLUSIONS: Tracheotomy in critically ill patients with COVID-19 who meet the indications for tracheotomy potentially represents a safer approach to manage the airway and help improve the treatment outcomes. A tracheotomy performed in the late phase of the disease has a relatively low risk of infection. Adherence to key steps in the tracheotomy procedure and donning adequate personal protection will help medical staff avoid infection.

Recommendations of the Spanish Society of Otolaryngology and Head and Neck Surgery for performing tracheotomies in patients infected by the coronavirus, Covid-19. / Recomendaciones de la Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello para la realización de traqueotomías en relación con pacientes infectados por coronavirus COVID-19.

The recent COVID-19 (coronavirus) pandemic is causing an increase in the number of patients who, due to their pulmonary ventilatory status, may require orotracheal intubation. COVID-19 infection has demonstrated a high rate of transmissibility, especially via the respiratory tract and by droplet spread. The Spanish Society of Otolaryngology and Head and Neck Surgery, based on the article by Wei et al. of 2003 regarding tracheotomies performed due to severe acute respiratory syndrome (SARS), has made a series of recommendations for the safe performance of tracheotomies.

Systematic review of international guidelines for tracheostomy in COVID-19 patients.

At this moment, the world lives under the SARS-CoV-2 outbreak pandemic. As Otolaryngologists - Head & Neck Surgeons, we need to perform and participate in examinations and procedures within the head and neck region and airway that carry a particularly high risk of exposure and infection because of aerosol and droplet contamination. One of those surgical procedures in demand at this moment is tracheostomy due the increasing ICU admissions. This review of international guidelines for tracheostomy in COVID-19 infected patients, aims to summarize in a systematic way the available recommendations: indications, timing, technique and safety measures for tracheostomy, from all over the world.

Tracheostomy intervention in intubated COVID positive patients: A survey of current clinical practice among ENT surgeons.

INTRODUCTION: The COVID-19 pandemic has resulted in an unprecedented need for critical care intervention. Prolonged intubation and mechanical ventilation has resulted in the need for tracheostomy in some patients. The purpose of this international survey was to assess optimal timing, technique and outcome for this intervention. METHODS: An online survey was generated. Otorhinolaryngologists from both the United Kingdom and Abroad were polled with regards to their experience of tracheostomy in COVID-19 positive ventilated patients. RESULTS: The survey was completed by 50 respondents from 16 nations. The number of ventilated patients totalled 3403, on average 9.7% required a tracheostomy. This was on average performed on day 14 following intubation. The majority of patients were successfully weaned (mean 7.4 days following tracheostomy). CONCLUSION: The results of this brief survey suggest that tracheostomy is of benefit in selected patients. There was insufficient data to suggest improved outcomes with either percutaneous vs an open surgical technique.

Tracheotomy in COVID-19 patients: Optimizing patient selection and identifying prognostic indicators.

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 preoperative and postoperative ventilation requirements and outcomes (ICU stay, time to decannulation, and death) were examined. RESULTS: Patients who sustained FiO2 ≤ 50% and PEEP ≤ 8 cm H2 O in the 24 hours pretracheotomy exhibited a favorable outcome. Those whose requirements remained below these thresholds post-tracheotomy could be safely stepped down after 48 hours. CONCLUSION: Sustained FiO2 ≤ 50% and PEEP ≤ 8 cm H2 O in the 48 hours 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.

Barrier device prototype for open tracheotomy during COVID-19 pandemic.

OBJECTIVE: To present a low-cost prototype for a barrier enclosure device which can be used during open surgeries such as tracheotomy. METHODS: We provide detailed description of a novel device called COVID-Box, developed by The Surgical Airway Team for COVID-19 Pandemic, a temporary task force formed by Walter Cantídio University Hospital. Safety guidelines for performing tracheotomies in COVID-19 patients are also stated. RESULTS: Our prototype device provides greater hand mobility than previous barrier devices reported, making it more suitable for airway surgical procedures, such as tracheotomy. The curved shaped format and the customizable access ports provides ergonomics, without compromising safety. CONCLUSION: The COVID-Box appears to be an efficient, reproduceable, low-cost barrier enclosure device that can be used for open tracheotomies in ICU patients during the COVID-19 pandemic.

Development of clinical care guidelines for faculty and residents in the era of COVID-19.

BACKGROUND: The global COVID-19 pandemic brings new challenges to otolaryngology resident education. Surgical volume and clinic visits are curtailed, personal protective equipment for operating room participation is restricted, and the risk of COVID-19 disease transmission during heretofore routine patient care is the new norm. METHODS: We describe a small-team "cohorting" protocol including guidelines for faculty and resident in common clinical scenarios with attention paid to the risk of common otolaryngologic procedures. RESULTS: A rotating small-team approach was implemented at each clinical site, limiting interaction between department members but providing comprehensive coverage. Faculty were involved at the earliest phase of clinical interactions. Guidelines delineated faculty and resident roles based on risk stratification by patient COVID status and anticipated procedures. Special consideration was given to high-risk procedures such as endoscopy and tracheotomy. CONCLUSIONS: A small-team-based approach with guidelines for faculty/resident roles may mitigate risk while optimizing patient care and maximizing education.

Surgical Considerations for an Awake Tracheotomy During the COVID-19 Pandemic.

Background: The current global COVID-19 pandemic is caused by the novel coronavirus Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Given that SARS-CoV-2 is highly transmissible, surgical societies have recommended that procedures with a high risk of aerosolization be avoided or delayed. However, some high-risk procedures, such as those related to head and neck malignancies, cannot always be delayed. Care must be taken during aerosol-generating procedures to minimize viral transmission as much as possible. Preoperative testing for COVID-19, limited operating room personnel, adequate personal protective equipment, and surgical technique are factors to consider for high-risk procedures. Methods: This article presents the case of an awake tracheotomy performed for a transglottic mass causing airway obstruction. Results: With detailed planning and specific techniques, the amount of aerosolization was reduced, and the procedure was performed as safely as possible. Conclusion: This case provides a template for future aerosol-generating procedures during respiratory pandemics.