Tracheostomy
Conditions
Keywords
tracheostomy, respiratory insufficiency, respiratory function tests, mechanical ventilators, rehabilitation, critical care
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.
Interventions
DEVICESealing device
Intratracheal tracheostomy sealing
DEVICENo device
Open tracheostomy wound
Sponsors
Aarhus University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | 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 | 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) | 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) | 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 |
Countries
Denmark
Outcome results
None listed