CompletedNot Applicable

Consequence of Open Versus Closed Tracheostomy Immediately After Decannulation

Denmark20 participantsStarted 2020-02-28

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Forced expiratory volume in one second (FEV1)

Timeframe: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention

Voice quality

Timeframe: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention

Peak expiratory flow (PEF)

Timeframe: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention

Forced vital capacity (FVC)

Timeframe: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention

Trial details

NCT IDNCT06138093

SponsorAarhus University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-12

View on ClinicalTrials.gov More Tracheostomy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Forced expiratory volume in one second (FEV1)

Timeframe: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention

Voice quality

Timeframe: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention

Peak expiratory flow (PEF)

Timeframe: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention

Forced vital capacity (FVC)

Timeframe: Day 2: At time of decannulation, i.e. directly after inclusion and randomization to sealing or not as first intervention