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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06346210
Enrollment
4000
Registered
2024-04-03
Start date
2024-04-02
Completion date
2024-04-02
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Critical care, Tracheostomy, Mechanical ventilation

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

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.

Interventions

PROCEDURETracheostomy

Surgery for tracheostomy

Sponsors

Uppsala University
Lead SponsorOTHER
Healthcare Region Dalarna
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ventilator free days alive60 days.Days alive without invasive mechanical ventilation during the first 60 days from start of invasive mechanical ventilation

Secondary

MeasureTime frameDescription
60 day mortality60 days.Mortality from any cause within 60 days from start of invasive mechanical intervention

Countries

Sweden

Contacts

PRINCIPAL_INVESTIGATORBjörn Ahlström, PhD

Uppsala University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026