Clinical trial NCT06346210: Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients
Official title: Optimal Timing for Tracheostomy in Invasively Mechanically Ventilated COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: Critical care
Tracheostomy
Mechanical ventilation
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Healthcare Region Dalarna
First posted: 2024-04-03
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Invasively mechanically ventilated adults in the Swedish intensive care registry.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ventilator free days alive
timeFrame: 60 days.
Secondary outcomes:
measure: 60 day mortality
timeFrame: 60 days.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Björn Ahlström, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.