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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06346210
• Other study ID #: UNT: U1111-1288-2037
• Status: Completed
• Start date: April 2, 2024
• Est. completion date: April 2, 2024

Study information

• Verified date: April 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: April 2, 2024
• Est. primary completion date: April 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• Tracheostomy
Surgery for tracheostomy

Locations

Country	Name	City	State
Sweden	Uppsala University	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Healthcare Region Dalarna

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Fu EL, Evans M, Carrero JJ, Putter H, Clase CM, Caskey FJ, Szymczak M, Torino C, Chesnaye NC, Jager KJ, Wanner C, Dekker FW, van Diepen M. Timing of dialysis initiation to reduce mortality and cardiovascular events in advanced chronic kidney disease: nationwide cohort study. BMJ. 2021 Nov 29;375:e066306. doi: 10.1136/bmj-2021-066306. — View Citation

Hernan MA, Robins JM. Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available. Am J Epidemiol. 2016 Apr 15;183(8):758-64. doi: 10.1093/aje/kwv254. Epub 2016 Mar 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator free days alive	Days alive without invasive mechanical ventilation during the first 60 days from start of invasive mechanical ventilation	60 days.
Secondary	60 day mortality	Mortality from any cause within 60 days from start of invasive mechanical intervention	60 days.