Instrumental respiratory physiotherapy for patients struggling to wean off ventilators
Randomized Controlled Trial Evaluating the Impact of Intensive, Instrumental and Early Respiratory Physiotherapy on Peak Expiratory Flow in Mechanically Ventilated Patients With ICU-acquired Muscle Weakness
This study tests if a new type of breathing therapy can help patients who have trouble getting off ventilators feel better and cough stronger than with regular therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 3 sites (Lyon, France and 2 other locations) |
| Trial ID | NCT06499389 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an early and systematic instrumental respiratory physiotherapy approach in patients who are difficult to wean off mechanical ventilation and have developed ICU-acquired neuromyopathy. The intervention aims to improve cough strength, measured by peak expiratory flow (PEF), compared to standard respiratory physiotherapy. By enhancing cough strength, the study seeks to reduce the risk of reintubation and improve patient outcomes during the weaning process from mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who have been on invasive mechanical ventilation for at least 48 hours and have failed at least one weaning test.
Not a fit: Patients with recent brain injuries, chronic neuromuscular pathologies, or those under continuous sedation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the weaning process for critically ill patients, reducing mortality and complications associated with prolonged mechanical ventilation.
How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown that enhancing cough strength can improve outcomes in patients with respiratory challenges.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lyon, France and 2 other locations
- Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN — Lyon, France, France (Not_yet_recruiting)
- Médecine Intensive - Réanimation, Hôpital de la Croix Rousse — Lyon, France (Recruiting)
- Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Maria CLEYET, MSc
- Email: maria.cleyet@chu-lyon.fr
- Phone: 04 26 10 94 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.