At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Intratracheal Sealing of Tracheostomy Immediately After Decannulation
In Brief
A clinical study evaluating Tracheostomy sealing for Tracheostomy Complications. Completed, enrolled 10 participants across 1 site.
Detailed 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 trachea. The aim is to improve lung function and voice quality, as well as to promote wound healing. Study procedure: A silicone sealing device will be inserted into the stoma tract. This may cause temporary discomfort around the site and may induce some coughing. You will then undergo a pulmonary function test - also known as a spirometry test. For the following 7 days, the sealing device will remain in the stoma tract and provide an airtight seal. You will be examined daily with spirometry, and the healing of the stoma tract will be closely monitored. A member of the research team will be present with you around the clock to ensure that the device remains correctly positioned. This is a safety precaution in the unlikely event that the sealing device dislocates into the airway. After 7 days, the sealing device will be removed through the nearly healed stoma tract simply by pulling it out. This may again cause slight irritation or coughing.
Study Details
Timeline
Interventions
A non-classified silicone-based prototype device designed to temporarily seal the tracheostomy tract from within the airway for up to 7 days after decannulation.