Timing of Tracheotomy in Covid-19 Patients (TTCOV19)

Sahlgrenska University Hospital

Status: Completed

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

Treatments: Procedure: Tracheotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04412356

HBergquist

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Early tracheotomy

Experimental group

Description:

Tracheotomy within 7 days after intubation.

Treatment:

Procedure: Tracheotomy

Late tracheotomy

Active Comparator group

Description:

Tracheotomy after at least 10 days after intubation.

Treatment:

Procedure: Tracheotomy