Timing of Tracheotomy in Covid-19 Patients

Study 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.

Official Title
-----------------
Timing of Tracheotomy in Covid-19 Positive Patients: a Randomized, Controlled Trial

Conditions
-----------------
Corona Virus Infection, Covid-19, ARDS, Tracheostomy Complication, Respiratory Insufficiency

Intervention / Treatment
-----------------
* Procedure: Tracheotomy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, single blinded, controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early tracheotomy<br>Tracheotomy within 7 days after intubation. | Procedure: Tracheotomy<br>* Surgical procedure to secure airway<br>|
| Active Comparator: Late tracheotomy<br>Tracheotomy after at least 10 days after intubation. | Procedure: Tracheotomy<br>* Surgical procedure to secure airway<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation | Number of days with mechanical ventilation | Through the individual ICU stay assessed up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay | Number of days at ICU | Through the individual ICU stay assessed up to 60 days | 
| Oxygen support | Number of days with need of additional oxygen support | Through the individual ICU stay assessed up to 60 days | 
| Sedation | Number of days with the need of sedation | Through the individual ICU stay assessed up to 60 days | 
| Adverse events | Various adverse events associated with the tracheotomy/tracheostomy | Through the individual ICU stay assessed up to 60 days | 
| Mortality | Mortality | Through the individual ICU stay assessed up to 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCT, Covid-19, Tracheotomy, Tracheostomy, ARDS