Timing of Tracheotomy in Covid-19 Patients

Not Applicable

Completed

• Conditions: Covid-19; ARDS; Respiratory Insufficiency; Tracheostomy Complication; Corona Virus Infection
• Interventions: Procedure: Tracheotomy

• Registration Number: NCT04412356
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-24
• Study First Submitted QC: 2020-05-31
• Study First Posted: 2020-06-02
• Study Start: 2020-06-06
• Primary Completion: 2021-06-01
• Status Verified: 2021-09
• Study Completion: 2021-09-20
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late tracheotomy	Tracheotomy	Tracheotomy after at least 10 days after intubation.
Early tracheotomy	Tracheotomy	Tracheotomy within 7 days after intubation.

Primary Outcome Measures

Name	Time	Method
Mechanical ventilation	Through the individual ICU stay assessed up to 60 days	Number of days with mechanical ventilation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden