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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Tracheostomy Complication, Covid19, Ventilator Lung

Intervention / Treatment
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* Procedure: Tracheostomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Tracheostomy|Tracheostomy is a procedure that creates a surgical airway in the windpipe to improve oxygenation of the lungs.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to wean | Clinical outcome in terms of time in days from tracheostomy to successful weaning from mechanical ventilation. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Airway related outcomes | Clinical outcome in terms of length of time from tracheostomy to tracheostomy decannulation. | 12 months | 
| Complications | Clinical outcome in terms of tracheostomy related complications in terms of bleeding, displaced tube, blocked tube, other. | 12 months | 
| 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 | 
| Mortality | Clinical outcomes in terms of patient mortality during or following tracheostomy, timing and cause of death | 12 months | 
| Adherence of tracheostomy procedure to national guidance | Following PPE guidance | 12 months | 
| Operator wellness | Symptomatic or test positive COVID-19 infection in healthcare professionals involved in the tracheostomy procedure. | 12 months |