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

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.

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Key information

Conditions

COVID-19 Pneumonia Extracorporeal Membrane Oxygenation Complication Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Tracheostomy Complication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamad Medical Corporation

Doha, 3050, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

over 18-years old.

Exclusion criteria

less than 18 years old,
Pregnancy
VA-ECMO

Treatment and study plan

Primary outcomes

External or endotracheal bleeding (mild, moderate, sever)

Time frame: 24 hours Post procedure

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

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Sep 16, 2021
Registry last updated: Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed