Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients

Uppsala University

Status: Completed

Conditions: COVID-19

Treatments: Procedure: Tracheostomy

Study type: Observational

Funder types: Other

Identifiers

NCT06346210

UNT: U1111-1288-2037

Details and patient eligibility

About

Tracheostomy is a medical procedure performed on the front of a persons neck. It is used to create a connection between the persons trachea and a mechanical ventilator instead of using a tube going through the mouth into the trachea, oral intubation. Living with a tracheostomy tube is less stressful compared to oral intubation and facilitate being awake and the start of training on spontaneous ventilation in mechanically ventilated patients. Studies of the timing of tracheostomy are either severely affected by methodological bias of to small to determine an effect. Thus, it is not known what the optimal timing of the tracheostomy is in mechanically ventilated COVID-19 patients.

Full description

Hypothesis It is hypothesised that timing of tracheostomy to day 9-11 is independently linked to a higher number of days, alive without invasive mechanical ventilation and several secondary outcomes when adequate methods to neutralize waiting time and immortal time bias are used.

Data sources Existing data provided for another project will be used.

Statistical methods:

A cohort study with a target trial emulation (1) on a dataset with cloned individuals assigned to different treatment strategies (i.e. tracheostomy at different timings). Censoring at deviation from assigned strategy or death (2). Adjustment for confounding will be used.

Enrollment: 4,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult
• admitted to an intensive care unit in Sweden from 2020 to 2021
• Main discharge diagnosis COVID-19 (ICD-10, U07.1)
• Invasive mechanical ventilation

Exclusion criteria

• No Swedish personal identification number.

Trial design

4,000 participants in 2 patient groups

Not tracheostomised

Description:

Invasively mechanically ventilated COVID-19 patients who did not receive a tracheostomy within 60 days from tracheal intubation.

Tracheostomised

Description:

Invasively mechanically ventilated COVID-19 patients who did receive a tracheostomy within 60 days from tracheal intubation.

Treatment:

Procedure: Tracheostomy