A Cohort Study of Mechanically Ventilated COVID-19 Patients Undergoing Tracheostomy

Covid19 Clinical Trial

— COVIDTrach  

Official title:

COVIDTrach; a UK National Cohort Study of Mechanically Ventilated COVID-19 Patients Undergoing Tracheostomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572438
• Other study ID #: Z6364106/0000/00/00
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: October 1, 2021

Study information

• Verified date: May 2022
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

COVIDTrach aims to assess the outcomes of tracheostomy in mechanically ventilated patients with COVID-19. The use of personal protective equipment and incidence of COVID-19 amongst operators is also recorded.

Description:

COVID-19 can lead to a severe respiratory illness with 5-12% requiring mechanical ventilation.Standard UK intensive care practice is to consider a tracheostomy after 7-10 days of mechanical ventilation in order to facilitate weaning, reduce duration of mechanical ventilation, shorten intensive care stay and reduce complications relating to prolonged presence of an endotracheal tube. Given the severity of respiratory illness and a mortality in mechanically ventilated COVID 19 patients which exceeds 50%, the benefit of tracheostomy in this group is uncertain.

There are also unique considerations regarding health care professional (HCP) safety when performing tracheostomy in COVID-19 patients due to the potential of aerosol generation and transmission of the infection. ENT UK and other organisations have issued guidance regarding surgical tracheostomy in terms of timing, environment, technique and level of personal protective equipment (PPE). The ability of hospital departments to follow this guidance and the effectiveness of these measures is unknown.

This UK national cohort study aims to assess the effects of tracheostomy in mechanically ventilated COVID-19 patients in terms of the duration of mechanical ventilation, length of ICU and hospital stay and mortality. These data will be related to COVID-19 patients who are mechanically ventilated but do not undergo tracheostomy, as captured by the UK Intensive Care National Audit and Research Centre (ICNARC).

In parallel we will collect data on the tracheostomy procedure itself and compare these to national guidance on tracheostomy in patients diagnosed with COVID-19, and on COVID-19 infections in the surgical and medical teams involved in the tracheostomy procedure.

This proposal builds upon the ongoing COVIDTrach project that has captured data on 550 COVID-19 tracheostomies from 78 NHS hospitals throughout the UK so far. COVIDTrach has successfully brought together surgical, intensive care and anaesthetic specialists to capture early timepoints following tracheostomy. Moving forward, we will work with speech and language therapists and physiotherapists to capture later stages in the patient pathway. This will provide a unique and comprehensive assessment of the role of tracheostomy in COVID-19 patients. It will lay the foundation for further much needed multidisciplinary research into the role of tracheostomy in respiratory disease beyond the COVID-19 pandemic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2234
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients

• Diagnosed with COVID-19

• Mechanically ventilated

• Undergoing elective surgical or percutaneous tracheostomy

• Health care professionals involved in the tracheostomy procedure (main operator and assistant)

Exclusion Criteria:

• COVID-19 patients undergoing an emergency tracheostomy;

• Patients younger than 18 years of age

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Tracheostomy Complication
• Ventilator Lung

Intervention

Procedure:
• Tracheostomy
Tracheostomy is a procedure that creates a surgical airway in the windpipe to improve oxygenation of the lungs.

Locations

Country	Name	City	State
United Kingdom	University College London NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to wean	Clinical outcome in terms of time in days from tracheostomy to successful weaning from mechanical ventilation.	12 months
Secondary	Airway related outcomes	Clinical outcome in terms of length of time from tracheostomy to tracheostomy decannulation.	12 months
Secondary	Complications	Clinical outcome in terms of tracheostomy related complications in terms of bleeding, displaced tube, blocked tube, other.	12 months
Secondary	Length of stay	Clinical outcome in terms of length of stay at intensive care and total length of stay in hospital in days.	12 months
Secondary	Mortality	Clinical outcomes in terms of patient mortality during or following tracheostomy, timing and cause of death	12 months
Secondary	Adherence of tracheostomy procedure to national guidance	Following PPE guidance	12 months
Secondary	Operator wellness	Symptomatic or test positive COVID-19 infection in healthcare professionals involved in the tracheostomy procedure.	12 months