Status:

COMPLETED

Intratracheal Tracheostomy Sealing - A Clinical Feasibility Study

Lead Sponsor:

University of Aarhus

Conditions:

Tracheostomy Complications

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this study is to investigate a new treatment method for tracheostomies - the term for the opening you have in your neck. The treatment method seals the stoma tract from within the trac...

Detailed Description

Background Tracheostomy is a surgical opening in the airway, most commonly performed as part of mechanical ventilation therapy. It is the most frequently performed surgical procedure in critically il...

Eligibility Criteria

Inclusion

  • Tracheostomy in place for ≥7 days for the purpose of mechanical ventilation in ICU
  • Age ≥18 years
  • Uncuffed or occluded tracheostomy tube (size 7-8) during the last 24 hours

Exclusion

  • Cognitive impairment or incapacity to such a degree that the participant is unable to comprehend study information or cooperate with the required assessments

Key Trial Info

Start Date :

January 20 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 8 2025

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT07149116

Start Date

January 20 2023

End Date

March 8 2025

Last Update

August 29 2025

Active Locations (1)

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1

Aarhus University Hospital

Aarhus, Denmark, 8200