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

NCT ID: NCT05045885

Last Updated: 2021-09-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-12-01

Brief Summary

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

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.

Conditions

COVID-19 Pneumonia; Extracorporeal Membrane Oxygenation Complication; Tracheostomy Complication; Respiratory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• over 18-years old.

Exclusion Criteria

• less than 18 years old,
• Pregnancy
• VA-ECMO

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Labib

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation - HMC

Locations

Hamad Medical Corporation

Doha, , Qatar

Countries

Qatar

References

WHO Director-General's opening remarks at the media briefing on COVID-19: 11 March 2020. Published March 11, 2020

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COVID Live Update: 189,294,523 Cases and 4,076,726 Deaths from the Coronavirus - Worldometer. Worldometers.info. https://www.worldometers.info/coronavirus/. Published 2021. Accessed July 15, 2021.

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Extracorporeal Life Support Organization - ECMO and ECLS. Elso.org. https://www.elso.org/COVID19.aspx. Published 2021. Accessed June 9, 2021.

Reference Type: BACKGROUND

Tracheotomy Recommendations During the COVID-19 Pandemic - American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). https://www.entnet.org/resource/tracheotomy-recommendations-during-the-covid-19-pandemic-2/. Published 2021. Accessed June 9, 2021.

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Other Identifiers

MRC-01-20-1196

Identifier Type: -

Identifier Source: org_study_id