ARDS, Corona Virus Infection, Covid-19, Respiratory Insufficiency, Tracheostomy Complication
Conditions
Keywords
Covid-19, Tracheotomy, Tracheostomy, RCT, ARDS
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.
Interventions
PROCEDURETracheotomy
Surgical procedure to secure airway
Sponsors
Sahlgrenska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to the randomization outcome.
Intervention model description
Randomized, single blinded, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical ventilation | Through the individual ICU stay assessed up to 60 days | Number of days with mechanical ventilation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed