UnknownNot Applicable

ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure

France300 participantsStarted 2021-09-28

Plain-language summary

Observational study in two medical-surgical intensive care units of the Clermont-Ferrand University Hospital to develop a composite score for prediction of 72h-extubation failure in patients at risk of extubation failure.

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 \> 18 years * Invasive mechanical ventilation for at least 48 hours * Criteria for ventilatory weaning are present * T-piece spontaneous breathing trial planned * Patients with a social security program Exclusion Criteria: * Patients already included in this study during the same stay in intensive care * Resuscitation neuromyopathy defined by an MRC (Medical Research Council) score \< 48/60 * Surgery planned within 72 hours * Prolonged ventilatory weaning (\>7 days after the first SBT) * Patients with tracheostomy * Patients with non-reintubation decision or terminal extubation * Brain damaged patients * Patients with ECMO/ECLS * Tetraplegic or paraplegic patients with lesion level higher than T8 * Nasotracheal intubated patients * Pregnant or breastfeeding women * Refusal to participate in the study (refusal by patient or family member/trusted person). * Patients under guardianship

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

The primary outcome measure is extubation failure, defined as the need for reintubation within 72 hours of extubation.

Timeframe: 72 hours

Trial details

NCT IDNCT05114551

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-09-28

Contact for this trial

Lise Laclautre

+33 4 73 754963 promo_interne_drci@chu-clermontferrand.fr

View on ClinicalTrials.gov More Mechanical Ventilator Weaning trials

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.