NCT04572438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

September 29, 2020

Last Update Submit

May 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to wean

    Clinical outcome in terms of time in days from tracheostomy to successful weaning from mechanical ventilation.

    12 months

Secondary Outcomes (6)

  • Airway related outcomes

    12 months

  • Complications

    12 months

  • Length of stay

    12 months

  • Mortality

    12 months

  • Adherence of tracheostomy procedure to national guidance

    12 months

  • +1 more secondary outcomes

Interventions

TracheostomyPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Mechanically ventilated patients with COVID-19 who undergo tracheostomy in the UK.

You may qualify if:

  • 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)

You may not qualify if:

  • COVID-19 patients undergoing an emergency tracheostomy;
  • Patients younger than 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London NHS Foundation Trust

London, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Interventions

Tracheostomy

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsOstomySurgical Procedures, OperativeOtorhinolaryngologic Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Nick JI Hamilton, MBChB PhD

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 1, 2020

Study Start

August 1, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations