Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning Fro… (NCT06185998) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Impact of the Nature and Interface of the Tracheostomy Cannula on Dyspnea in Patients Weaning From Artificial Ventilation in Weaning Unit
76 participantsStarted 2024-09
Plain-language summary
This trial aims to assess dyspnea intensity in tracheostomized patients undergoing prolonged artificial ventilation weaning. The primary outcome is dyspnea measured by the Visual Analogue Scale (VAS-Dyspnea). A comparison between low-pressure balloon tracheostomy cannula and plated balloon cannula and four interfaces (Cap, ventilator, phonation valve, or filter) are tested. The secondary outcomes including Multidimensional Dyspnea Profile, pain, anxiety VAS, and tolerance under different interfaces. The multicenter, cross-over study involves 76 patients over 25 months, each serving as their own control. Cap is always evaluated first but the order of the three interfaces (ventilator, phonation valve, or filter) and type of cannula are chosen by randomization. The study is conducted in three weaning centers (SRPR units) at Pitié-Salpêtrière, Bligny, and Forcilles.
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:
* Patient aged 18 years or older
* Patient admitted to SRPR with respiratory and hemodynamic stability
* Patient with a tracheostomy tube
* Deflated balloon for more than 6 hours per day
* Able to tolerate at least 1 hour on cap and phonation valve (deflated balloon)
* Able to remain at least 3 consecutive hours without ventilation
* Patient with at least one non-zero dyspnea numerical rating scale (NRS) score in the 72 hours preceding inclusion
* Able to respond to self-administered questionnaires on dyspnea
* Patients affiliated with a social security system or beneficiaries of such a system (excluding State Medical Assistance)
* Patients who have given their informed consent
* No significant expected changes in the administration of anxiolytic and analgesic treatments with anti-dyspneic properties within 2 days
Exclusion Criteria:
* Pregnant women (verified by a blood or urine test during hospitalization for all women of childbearing age)
* Patients deprived of liberty or under legal protection (guardianship or curatorship)
* Patients unable to consent to the research
* Contraindication to the use of a 7 mm tracheostomy tube
* Patient presenting the combination of major swallowing disorders and excessive salivary secretion making the deflation of the tracheostomy tube balloon
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.