An observational study in Tracheostomy Complication, Covid19 and Ventilator Lung, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University College, London · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 2,234 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Mechanically ventilated patients with COVID-19 who undergo tracheostomy in the UK.
Exclusion Criteria:
Tracheostomy is a procedure that creates a surgical airway in the windpipe to improve oxygenation of the lungs.
Time to wean
Clinical outcome in terms of time in days from tracheostomy to successful weaning from mechanical ventilation.
Time frame: 12 months
Airway related outcomes
Clinical outcome in terms of length of time from tracheostomy to tracheostomy decannulation.
Time frame: 12 months
Complications
Clinical outcome in terms of tracheostomy related complications in terms of bleeding, displaced tube, blocked tube, other.
Time frame: 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.
Time frame: 12 months
Mortality
Clinical outcomes in terms of patient mortality during or following tracheostomy, timing and cause of death
Time frame: 12 months
Adherence of tracheostomy procedure to national guidance
Following PPE guidance
Time frame: 12 months
Operator wellness
Symptomatic or test positive COVID-19 infection in healthcare professionals involved in the tracheostomy procedure.
Time frame: 12 months
Plan to share: Undecided
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University College, London