Safety and Feasibility of Percutaneous Dilatational Tracheostomy in Patients With Severe COVID-19 Supported by ECMO

Study Overview
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Brief Summary
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COVID-19 pandemic has presented the global health care systems with unprecedented and unexpected challenges. The clinical spectrum of COVID-19 disease varies from mild, at times asymptomatic, to severe life-threatening multiple organ dysfunction and shock. The latter group, albeit represent less than 10% of all SARS-CoV-2 infections will require ICU admission, multi-modal organ support including Extracorporeal Membrane Oxygenation (ECMO) for severe refractory cardiac and/or pulmonary failure. Prolonged mechanical ventilation is a typical indication for tracheostomy. Percutaneous tracheostomy at the bedside has several advantages over surgical tracheostomy. However, with the emerging pandemic, there is a lack of literature regarding the safety of percutaneous bedside tracheostomy for patients with COVID-19 supported by ECMO. Our study aims to describe the safety of bedside percutaneous dilatational tracheostomy of confirmed COVID-19 positive patients supported on ECMO.

Detailed Description
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At the time of writing, more than 50 million confirmed cases of COVID-19 have been reported worldwide with over one million reported deaths1 Data about ICU mortality is variable and may be affected by the infrastructure of the health care system in each country, however, the estimated mortality rate in COVID-19 patients who need ICU is 25.7%-35.7%2. The World Health Organization (WHO) suggests ECMO for COVID-19 patients with severe ARDS not responding to conventional treatment. However, Extracorporeal Life Support Organization (ESLSO) guidance recommends a balance of resource utilization, allocation, and appropriate case selection3. According to ELSO Registry; 3048 COVID-19 cases have been supported on ECMO. Interestingly discharge alive rate was reported to be over 60%4. Tracheostomy can be performed with two different techniques. Open 'surgical' tracheostomy (OT) and percutaneous dilatational tracheostomy (PDT). The later was favored during the SARS outbreak (SARS-CoV-1). However, the literature is not clear yet about the preferable and safest technique during Covid-19 disease SARS-CoV-2 as both procedures could be aerosol-generating procedures (AGP)5,6. SARS-CoV-2 is highly contagious and can spread via aerosol, contact, and droplet. This poses a significant risk to health care workers (HCW) and in particular during airway interventions and procedures. The optimal time to perform tracheostomy in COVID-19 patients remains controversial. Recommendations are different whether early or late tracheostomy is the preferred one, however, the American Academy of Otolaryngology-Head and Neck surgery recommend the procedure to take a place 2-3 weeks after intubation5,6. Generally speaking, tracheostomy has many advantages in critically ill patients such as reducing the days of mechanical ventilation, reduce ICU admission, reduce nosocomial pneumonia in special groups7,8. Tracheostomy carries the second-highest risk of transmission of infection to staff after endotracheal intubation. PDT in patients supported on ECMO is not without risks. Bleeding is a major concern and has been reported at 40%9-11. Other reported procedural complications are mechanical and ECMO-circuit dysfunction9-12. The literature search revealed one case series from the UK13 of PDT in the same patient population as our study. However, the report focuses on the description of the procedure rather than the safety aspect. To my knowledge, this is the first study to look in-depth into staff and patient safety of PDT in COVID-19 positive patients on ECMO support.

Official Title
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Safety and Feasibility of Percutaneous Dilatational Tracheostomy in Patients With Severe COVID-19 Disease Supported by Extracorporeal Membrane Oxygenation.

Conditions
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COVID-19 Pneumonia, Extracorporeal Membrane Oxygenation Complication, Tracheostomy Complication, Respiratory Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18-years old. Exclusion Criteria: less than 18 years old, Pregnancy VA-ECMO

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| External or endotracheal bleeding (mild, moderate, sever) | Mild: Minimal external or endotracheal bleeding with minimal or no drop-in haemoglobin and no surgical intervention. Moderate: Obvious external or endotracheal bleed. A drop-in haemoglobin of less than one gram/dL or transfusion of one unit of red blood cells. Severe bleeding: a drop of two grams or more in haemoglobin/dL and/or transfusion of two or more red cell packs or other blood products, disseminated intravascular coagulopathy (DIC) or need for surgical intervention | 24 hours Post procedure |