NCT06346210

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
PROCEDURE	Tracheostomy	Surgery for tracheostomy

Timeline

• Start date: 2024-04-02
• Primary completion: 2024-04-02
• Completion: 2024-04-02
• First posted: 2024-04-03
• Last updated: 2024-04-10

Locations

1 site across 1 country: Sweden