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OpenTrials
Completed

NCT Number: NCT06346210

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University

Uppsala, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tracheostomy

Procedure

Surgery for tracheostomy

Primary outcomes

  1. Ventilator free days alive

    Time frame: 60 days.

    Days alive without invasive mechanical ventilation during the first 60 days from start of invasive mechanical ventilation

Secondary outcomes

  1. 60 day mortality

    Time frame: 60 days.

    Mortality from any cause within 60 days from start of invasive mechanical intervention

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Healthcare Region Dalarna

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 3, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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