Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning P… (NCT03512054) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study Evaluating the Success (= Safe Decannulation) of a Standardized Tracheotomy Weaning Procedure in Brain-injury's Patients
France30 participantsStarted 2018-06-20
Plain-language summary
Tracheotomy weaning and decannulation are one of the important problems in the neurosurgical care unit. Aside from medical, psychological, sociological, economical and ethics problems, tracheotomy increases the duration of the hospital stay and conditions the secondarily future medical care (better re-education after the injury).
However, according to investigators practices, that patients who were decannulated with success can go into a secondary care residence more easily.
This research will demonstrate that all patients included can be decannulated without risk of a new recannulation in the 96 hours.
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:
* age at least 18 years old
* brain-injury disease
* tracheotomy act while in neurosurgery or reanimation stay
* no artificial ventilation
* medical cover
* free, informed and express consent by the patient or his legal representative (no later than the day after the inclusion and before all exam necessary for the research)
Exclusion Criteria:
Malnutrition (defines by the age) :
* age \< 70 years old: body mass index (B.D.I.) \<16 kg/m² or albuminemia \<20 g/L
* age \> 70 years old: body mass index (B.D.I.) \<18 kg/m² or albuminemia \<30 g/L
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
1
Number of safe decannulation
Timeframe: Up to 3 month after weaning procedure start (Inclusion)