Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tracheostomy
- Sponsor
- Aarhus University Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Forced expiratory volume in one second (FEV1)
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Tracheostomy for minimum 7 days
- •Age \> 18 years
- •Capped uncuffed tube size 7 or 8 for at least 24 hours
Exclusion Criteria
- •Cognitive dysfunction (patients who are not able to cooperate with investigation)
Outcomes
Primary Outcomes
Forced expiratory volume in one second (FEV1)
Time Frame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Lung function / air flow evaluated by spirometry
Voice quality
Time Frame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Evaluated by Equal-Appearing Interval Scale ranging from 1 to 5, where 5 represents a normal voice quality and 1 represents a severely impaired voice
Peak expiratory flow (PEF)
Time Frame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Lung function / air flow evaluated by spirometry
Forced vital capacity (FVC)
Time Frame: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention
Lung function / air flow evaluated by spirometry