Timing of Tracheotomy in Covid-19 Patients

Covid-19 Clinical Trial

— TTCOV19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412356
• Other study ID #: HBergquist
• Status: Completed
• Phase: N/A
• Start date: June 6, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: September 2021
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 20, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Tracheostomy Complication

Intervention

Procedure:
• Tracheotomy
Surgical procedure to secure airway

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical ventilation	Number of days with mechanical ventilation	Through the individual ICU stay assessed up to 60 days
Secondary	ICU stay	Number of days at ICU	Through the individual ICU stay assessed up to 60 days
Secondary	Oxygen support	Number of days with need of additional oxygen support	Through the individual ICU stay assessed up to 60 days
Secondary	Sedation	Number of days with the need of sedation	Through the individual ICU stay assessed up to 60 days
Secondary	Adverse events	Various adverse events associated with the tracheotomy/tracheostomy	Through the individual ICU stay assessed up to 60 days
Secondary	Mortality	Mortality	Through the individual ICU stay assessed up to 90 days