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

Completed

• Conditions: COVID-19
• Interventions: Procedure: Tracheostomy

• Registration Number: NCT06346210
• Lead Sponsor: Uppsala University

Brief 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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-02
• Primary Completion: 2024-04-02
• Study Completion: 2024-04-02
• Study First Submitted: 2024-04-02
• Study First Submitted QC: 2024-04-02
• Study First Posted: 2024-04-03
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Tracheostomised	Tracheostomy	Invasively mechanically ventilated COVID-19 patients who did receive a tracheostomy within 60 days from tracheal intubation.

Primary Outcome Measures

Name	Time	Method
Ventilator free days alive	60 days.	Days alive without invasive mechanical ventilation during the first 60 days from start of invasive mechanical ventilation

Secondary Outcome Measures

Name	Time	Method
60 day mortality	60 days.	Mortality from any cause within 60 days from start of invasive mechanical intervention

Trial Locations

Locations (1)

Uppsala University; 🇸🇪 Uppsala, Sweden