Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
Recruiting now · Not applicable
Conditions studied: Ventilator Weaning
In brief
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.
Key facts
- Study ID
- NCT06499389
- Run by
- Hospices Civils de Lyon
- People needed
- 50
- Starts
- 2025-03-18
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-01-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Médecine Intensive - Réanimation, Hôpital de la Croix Rousse — Lyon, France (enrolling)
- Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud — Lyon, France (enrolling)
- Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN — Lyon, France, France
Full record on ClinicalTrials.gov
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