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

NCT06346210 | Completed

• 1 other identifier: UNT: U1111-1288-2037
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Critical care; Tracheostomy; Mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Ventilator free days alive

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

  60 days.

Secondary Outcomes (1)

• 60 day mortality

  60 days.

Study Arms (2)

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

Interventions

Tracheostomy PROCEDURE

Surgery for tracheostomy

Tracheostomised

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Invasively mechanically ventilated adults in the Swedish intensive care registry.

You may qualify if:

• 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

You may not qualify if:

• No Swedish personal identification number.

Sponsors & Collaborators

• Uppsala University: lead
• Healthcare Region Dalarna: collaborator

Study Sites (1)

Uppsala University

Uppsala, Sweden

Location

MeSH Terms

Conditions

COVID-19

Interventions

Tracheostomy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Ostomy; Surgical Procedures, Operative; Otorhinolaryngologic Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Björn Ahlström, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 3, 2024
• Study Start: April 2, 2024
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)