TTCOV19: Timing of Tracheotomy in Covid-19 Patients

Sponsor
Sahlgrenska University Hospital, Sweden (Other)
Overall Status
Completed
CT.gov ID
NCT04412356
Collaborator
(none)
150
1
2
15.5
9.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Tracheotomy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, single blinded, controlled trialRandomized, single blinded, controlled trial
Masking:
Single (Participant)
Masking Description:
Patients will be blinded to the randomization outcome.
Primary Purpose:
Treatment
Official Title:
Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial
Actual Study Start Date :
Jun 6, 2020
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Sep 20, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Mechanical ventilation [Through the individual ICU stay assessed up to 60 days]

    Number of days with mechanical ventilation

Secondary Outcome Measures

  1. ICU stay [Through the individual ICU stay assessed up to 60 days]

    Number of days at ICU

  2. Oxygen support [Through the individual ICU stay assessed up to 60 days]

    Number of days with need of additional oxygen support

  3. Sedation [Through the individual ICU stay assessed up to 60 days]

    Number of days with the need of sedation

  4. Adverse events [Through the individual ICU stay assessed up to 60 days]

    Various adverse events associated with the tracheotomy/tracheostomy

  5. Mortality [Through the individual ICU stay assessed up to 90 days]

    Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sahlgrenska University Hospital Gothenburg Sweden

Sponsors and Collaborators

  • Sahlgrenska University Hospital, Sweden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Henrik Bergquist, MD, PhD, Associate Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT04412356
Other Study ID Numbers:
  • HBergquist
First Posted:
Jun 2, 2020
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Henrik Bergquist, MD, PhD, Associate Professor, Sahlgrenska University Hospital, Sweden
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 22, 2021