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Timing of Tracheotomy in Covid-19 Patients (TTCOV19)

Primary Purpose

Covid-19, ARDS, Tracheostomy Complication

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Tracheotomy
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid-19 focused on measuring Covid-19, Tracheotomy, Tracheostomy, RCT, ARDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early tracheotomy

Late tracheotomy

Arm Description

Tracheotomy within 7 days after intubation.

Tracheotomy after at least 10 days after intubation.

Outcomes

Primary Outcome Measures

Mechanical ventilation
Number of days with mechanical ventilation

Secondary Outcome Measures

ICU stay
Number of days at ICU
Oxygen support
Number of days with need of additional oxygen support
Sedation
Number of days with the need of sedation
Adverse events
Various adverse events associated with the tracheotomy/tracheostomy
Mortality
Mortality

Full Information

First Posted
May 24, 2020
Last Updated
September 20, 2021
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT04412356
Brief Title
Timing of Tracheotomy in Covid-19 Patients
Acronym
TTCOV19
Official Title
Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, ARDS, Tracheostomy Complication, Respiratory Insufficiency, Corona Virus Infection
Keywords
Covid-19, Tracheotomy, Tracheostomy, RCT, ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single blinded, controlled trial
Masking
Participant
Masking Description
Patients will be blinded to the randomization outcome.
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early tracheotomy
Arm Type
Experimental
Arm Description
Tracheotomy within 7 days after intubation.
Arm Title
Late tracheotomy
Arm Type
Active Comparator
Arm Description
Tracheotomy after at least 10 days after intubation.
Intervention Type
Procedure
Intervention Name(s)
Tracheotomy
Intervention Description
Surgical procedure to secure airway
Primary Outcome Measure Information:
Title
Mechanical ventilation
Description
Number of days with mechanical ventilation
Time Frame
Through the individual ICU stay assessed up to 60 days
Secondary Outcome Measure Information:
Title
ICU stay
Description
Number of days at ICU
Time Frame
Through the individual ICU stay assessed up to 60 days
Title
Oxygen support
Description
Number of days with need of additional oxygen support
Time Frame
Through the individual ICU stay assessed up to 60 days
Title
Sedation
Description
Number of days with the need of sedation
Time Frame
Through the individual ICU stay assessed up to 60 days
Title
Adverse events
Description
Various adverse events associated with the tracheotomy/tracheostomy
Time Frame
Through the individual ICU stay assessed up to 60 days
Title
Mortality
Description
Mortality
Time Frame
Through the individual ICU stay assessed up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Bergquist, Assoc Prof
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
35585614
Citation
Eeg-Olofsson M, Pauli N, Hafsten L, Jacobsson J, Lundborg C, Brink M, Larsson H, Lindell E, Lowhagen K, Gisslen M, Bergquist H. TTCOV19: timing of tracheotomy in SARS-CoV-2-infected patients: a multicentre, single-blinded, randomized, controlled trial. Crit Care. 2022 May 18;26(1):142. doi: 10.1186/s13054-022-04005-0.
Results Reference
derived

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Timing of Tracheotomy in Covid-19 Patients

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