NCT06499389 Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
| NCT ID | NCT06499389 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Ventilator Weaning |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-03-18 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06499389 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventilator Weaning. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06499389 currently recruiting?
Yes, NCT06499389 is actively recruiting participants. Contact the research team at maria.cleyet@chu-lyon.fr for enrollment information.
Where is the NCT06499389 trial being conducted?
This trial is being conducted at Lyon, France, Lyon, France, Lyon, France.
Who is sponsoring the NCT06499389 clinical trial?
NCT06499389 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 50 participants.