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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Procedure: Tracheostomy

Detailed Description

The study hypothesis is that a strategy of tracheostomy during the second week of mechanical ventilation yields more IMV-free days and lower mortality than continued mechanical ventilation without tracheostomy, when efforts are made to neutralize immortal time bias.

The hypothesis has been slightly changed to accommodate the methods change described below.

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

Statistical methods:

A Markov multistate model with inverse probability weighting and landmark analyses at 7, 14, and 21 days from IMV start. The primary outcome is estimated ventilator-free days alive at day 60; secondary analyses includes 60-day mortality.

The methods has been changed to multistate + landmark because the data did not support a full cloning, censoring, weighing approach.

• Study Type: Observational
• Enrollment (Actual): 4000

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • Uppsala University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Invasively mechanically ventilated adults in the Swedish intensive care registry.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Not tracheostomised; Invasively mechanically ventilated COVID-19 patients who did not receive a tracheostomy within 60 days from tracheal intubation.
Tracheostomised; Invasively mechanically ventilated COVID-19 patients who did receive a tracheostomy within 60 days from tracheal intubation.	Procedure: Tracheostomy; Surgery for tracheostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilator free days alive	Days alive without invasive mechanical ventilation during the first 60 days from start of invasive mechanical ventilation	60 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
60 day mortality	Mortality from any cause within 60 days from start of invasive mechanical intervention	60 days.

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Healthcare Region Dalarna
• Investigators: Principal Investigator: Björn Ahlström, PhD, Uppsala University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Actual): April 2, 2024
• Study Completion (Actual): April 2, 2024

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Critical care; Tracheostomy; Mechanical ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Therapeutics; Surgical Procedures, Operative; Airway Management; Thoracic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Ostomy; Tracheostomy
• Other Study ID Numbers: UNT: U1111-1288-2037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient data will be shared under the regulations of the European general data protection act and after researchers obtain relevant permissions from the Swedish ethical review authority.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No