Timing of Tracheotomy in Covid-19 Patients (TTCOV19)

September 20, 2021 updated by: Henrik Bergquist, Sahlgrenska University Hospital, Sweden

Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial

Critically ill covid-19 patients may require respiratory support including mechanical ventilation. After an initial period with an endotracheal tube, a tracheotomy is performed in order to reduce potential airway complications, reduce the need of sedation and facilitate the monitoring and recovery. The optimal timing of this surgical procedure is, however, still unknown. The aim of this randomized, controlled trial is to compare the outcome of early (within 7 days after intubation) vs late (at least 10 days after intubation) tracheotomy in covid-19 patients. The need for mechanical ventilation, sedation, additional oxygen support, frequency of complications, duration at the ICU and mortality through the ICU stay will be evaluated and compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Verified Covid-19 infection
  • Intubated due to respiratory insufficiency and need for mechanical ventilation
  • Informed consent from patient or relative

Exclusion Criteria:

  • Age below 18 years
  • Need for mechanical ventilation less than 14 days
  • Tracheotomy not possible within 7 days
  • Tracheotomy not possible due to anatomical or other medical reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early tracheotomy
Tracheotomy within 7 days after intubation.
Procedure: Tracheotomy
Surgical procedure to secure airway
Active Comparator: Late tracheotomy
Tracheotomy after at least 10 days after intubation.
Procedure: Tracheotomy
Surgical procedure to secure airway

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mechanical ventilation
Time Frame: Through the individual ICU stay assessed up to 60 days
Number of days with mechanical ventilation
Through the individual ICU stay assessed up to 60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU stay
Time Frame: Through the individual ICU stay assessed up to 60 days
Number of days at ICU
Through the individual ICU stay assessed up to 60 days
Oxygen support
Time Frame: Through the individual ICU stay assessed up to 60 days
Number of days with need of additional oxygen support
Through the individual ICU stay assessed up to 60 days
Sedation
Time Frame: Through the individual ICU stay assessed up to 60 days
Number of days with the need of sedation
Through the individual ICU stay assessed up to 60 days
Adverse events
Time Frame: Through the individual ICU stay assessed up to 60 days
Various adverse events associated with the tracheotomy/tracheostomy
Through the individual ICU stay assessed up to 60 days
Mortality
Time Frame: Through the individual ICU stay assessed up to 90 days
Mortality
Through the individual ICU stay assessed up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Investigators

  • Principal Investigator: Henrik Bergquist, Assoc Prof, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

September 20, 2021

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

May 31, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBergquist

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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