CompletedNot Applicable

Determinants of Successful Decannulation in Difficult-to-wean Patients

France100 participantsStarted 2021-04-15

Plain-language summary

The factors of success of decannulation are not well known in the literature and the decision to decannulate is mainly based on clinical judgment. The failure rate of decannulation is between 2 and 25% with a poor prognosis in case of failure. The objective of this study is to determine the factors associated with successful tracheostomy removal in patients hospitalized in a respiratory weaning unit. The secondary objectives are to evaluate in tracheostomized and hospitalized patients in weaning unit: * The prevalence of successful tracheostomy removal; * The prevalence of successful weaning from mechanical ventilation; * Factors associated with successful weaning from mechanical ventilation; * Demographic characteristics of these patients at admission; * Ventilatory characteristics of these patients at admission; * Biological characteristics of these patients at admission; This is a prospective, single-centre, interventional cohort study with an expected duration of 2 years. All patients admitted to the respiratory weaning unit in the Forcilles' hospital, with a tracheostomy and an expected duration of mechanical ventilation \> 48 hours will be consecutively included. All factors potentially associated with successful tracheostomy removal will be prospectively collected: severity factors related to the ICU stay, ventilatory factors, respiratory and extra-respiratory factors.

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: * Hospitalized in weaning unit * Presence of a tracheostomy at admission; * Expected duration of mechanical ventilation \>48h at admission; Exclusion Criteria: * Known pregnancy; * Patient with protective measure of justice; * Patient under guardianship or curators; * Data access denial

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

Proportion of patients successfully liberated from the tracheostomy

Timeframe: After 48 hours of spontaneous breathing

Trial details

NCT IDNCT04841889

SponsorHopital Forcilles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-15

View on ClinicalTrials.gov More Tracheostomy trials