TTCOV19: Timing of Tracheotomy in Covid-19 Patients
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 |
---|---|---|
|
N/A |
Study Design
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
- Mechanical ventilation [Through the individual ICU stay assessed up to 60 days]
Number of days with mechanical ventilation
Secondary Outcome Measures
- ICU stay [Through the individual ICU stay assessed up to 60 days]
Number of days at ICU
- Oxygen support [Through the individual ICU stay assessed up to 60 days]
Number of days with need of additional oxygen support
- Sedation [Through the individual ICU stay assessed up to 60 days]
Number of days with the need of sedation
- Adverse events [Through the individual ICU stay assessed up to 60 days]
Various adverse events associated with the tracheotomy/tracheostomy
- Mortality [Through the individual ICU stay assessed up to 90 days]
Mortality
Eligibility Criteria
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
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.- HBergquist