Trials / Completed
CompletedNCT06138093
Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Aarhus University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Tracheostomy is performed for prolonged mechanical ventilation. Ineffective bandaging following decannulation leaves the tracheostomy wound unsealed, reducing pulmonary function, coughing ability, and voice quality, ultimately leading to decannulation failure. Recently, a new concept enabling intratracheal sealing of the tracheotomy was introduced, potentially solving the issues of air leakage and tracheal wound infection. This study aims to investigate the feasibility of intratracheal tracheostomy sealing in relation to an immediate normalization of physiological airway flow and an improved voice quality.
Detailed description
See protocol document.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Sealing device | Intratracheal tracheostomy sealing |
| DEVICE | No device | Open tracheostomy wound |
Timeline
- Start date
- 2020-02-28
- Primary completion
- 2022-01-12
- Completion
- 2023-06-01
- First posted
- 2023-11-18
- Last updated
- 2024-12-20
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT06138093. Inclusion in this directory is not an endorsement.