Clinical trial NCT04572438: A Cohort Study of Mechanically Ventilated COVID-19 Patients Undergoing Tracheostomy
Official title: COVIDTrach; a UK National Cohort Study of Mechanically Ventilated COVID-19 Patients Undergoing Tracheostomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tracheostomy Complication
Covid19
Ventilator Lung
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-10-01
Enrollment: 2234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients with COVID-19 who undergo tracheostomy in the UK.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to wean
timeFrame: 12 months
Secondary outcomes:
measure: Airway related outcomes
timeFrame: 12 months
measure: Complications
timeFrame: 12 months
measure: Length of stay
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Adherence of tracheostomy procedure to national guidance
timeFrame: 12 months
measure: Operator wellness
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London NHS Foundation Trust
Study officials:
affiliation: University College, London
name: Nick JI Hamilton, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: COVIDTrach collaborative. COVIDTrach: a prospective cohort study of mechanically ventilated patients with COVID-19 undergoing tracheostomy in the UK. BMJ Surg Interv Health Technol. 2021 Jul;3(1):e000077. doi: 10.1136/bmjsit-2020-000077. Epub 2021 Jul 8.