Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Covid-19
- Sponsor
- Sahlgrenska University Hospital, Sweden
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Mechanical ventilation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Henrik Bergquist
MD, PhD, Associate Professor
Sahlgrenska University Hospital, Sweden
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
Outcomes
Primary Outcomes
Mechanical ventilation
Time Frame: Through the individual ICU stay assessed up to 60 days
Number of days with mechanical ventilation
Secondary Outcomes
- Mortality(Through the individual ICU stay assessed up to 90 days)
- ICU stay(Through the individual ICU stay assessed up to 60 days)
- Adverse events(Through the individual ICU stay assessed up to 60 days)
- Sedation(Through the individual ICU stay assessed up to 60 days)
- Oxygen support(Through the individual ICU stay assessed up to 60 days)