Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
France50 participantsStarted 2025-03-18
Plain-language summary
Difficult ventilatory weaning is associated with a 20% mortality rate. 40% of these patients will develop intensive care unit (ICU)-acquired neuromyopathy, associated with reduced cough strength and a 4-fold increase in the risk of reintubation. The objective measure of cough strength is peak expiratory flow (PEF). Instrument-assisted coughing is a respiratory physiotherapy technique capable of significantly increasing PEF in chronic neuromuscular patients and draining bronchial secretions.
The objective of the study is to determine whether an early, systematic, instrumental, intensive respiratory physiotherapy strategy in patients with difficult ventilatory weaning and ICU-acquired neuromyopathy significantly improves PEF immediately prior to extubation, compared with a conventional, protocolized management strategy.
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 18 years or more, affiliated to a social security system
* Patients on invasive mechanical ventilation for 48 hours or more
* Failure of at least one mechanical ventilation weaning test (spontaneous breathing trial, SBT)
* First successful SBT on the day of eligibility assessment
* Medical Research Council (MRC) score \< 48 and/or cough strength ≤ 2 on the 6-point Likert scale
Exclusion Criteria:
* Recent brain injury (\< 3 months, stroke, cardiopulmonary arrest)
* Delirium tremens (Cushman score \> 7)
* Chronic neuromuscular pathology
* Patient under continuous intravenous sedation
* Patient unresponsive to simple commands and Richmond Agitation and Sedation Scale (RASS) score \< -2 or \> +1
* FiO2: Inspired Oxygen Fraction\> 50%, percutaneous, O2: oxygen saturation \< 88%, positive end-expiratory pressure \> 5 centimeter of water (cmH2O) or respiratory rate ≥ 35 min-1
* Vasopressor catecholamine at a dose \> 0.5 μg/kg/min
* Tracheostomized patient
* Undrained pneumothorax
* Pulmonary emphysema (identified as antecedent in medical record)
* Uncontrolled hemoptysis
* Surgery \< 3 months of esophagus and/or the ear, nose and throat (ENT) sphere
* Pregnancy or lactating
* Patient deprived of liberty by judicial or administrative decision
* Patient under guardianship or curatorship
* Patient already included in the same study or in another study sharing the same primary endpoint
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
Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort