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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04572438
Recruitment Status : Completed
First Posted : October 1, 2020
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment
Tracheostomy Complication Covid19 Ventilator Lung Procedure: Tracheostomy

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.

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Study Type : Observational
Actual Enrollment : 2234 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVIDTrach; a UK National Cohort Study of Mechanically Ventilated COVID-19 Patients Undergoing Tracheostomy
Actual Study Start Date : August 1, 2020
Actual Primary Completion Date : October 1, 2021
Actual Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Time to wean [ Time Frame: 12 months ]
    Clinical outcome in terms of time in days from tracheostomy to successful weaning from mechanical ventilation.


Secondary Outcome Measures :
  1. Airway related outcomes [ Time Frame: 12 months ]
    Clinical outcome in terms of length of time from tracheostomy to tracheostomy decannulation.

  2. Complications [ Time Frame: 12 months ]
    Clinical outcome in terms of tracheostomy related complications in terms of bleeding, displaced tube, blocked tube, other.

  3. Length of stay [ Time Frame: 12 months ]
    Clinical outcome in terms of length of stay at intensive care and total length of stay in hospital in days.

  4. Mortality [ Time Frame: 12 months ]
    Clinical outcomes in terms of patient mortality during or following tracheostomy, timing and cause of death

  5. Adherence of tracheostomy procedure to national guidance [ Time Frame: 12 months ]
    Following PPE guidance

  6. Operator wellness [ Time Frame: 12 months ]
    Symptomatic or test positive COVID-19 infection in healthcare professionals involved in the tracheostomy procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Mechanically ventilated patients with COVID-19 who undergo tracheostomy in the UK.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04572438


Locations
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United Kingdom
University College London NHS Foundation Trust
London, United Kingdom
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Nick JI Hamilton, MBChB PhD University College, London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04572438    
Other Study ID Numbers: Z6364106/0000/00/00
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases