Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
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
Hospices Civils de Lyon
50 participants
Mar 18, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria16
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients randomized to this group will receive 3 sessions per day of intensive early respiratory physiotherapy with instrumental techniques from randomization to day 7, before and after any extubation. The strategy will be applied until day 7 of randomization, regardless of the patient's status (intubated or not).
Patients in this group will receive standardized and protocolized respiratory physiotherapy to reproduce the usual practices of non-expert centers,1 to 2 sessions of manual respiratory physiotherapy (not assisted by an instrumental technique) per day until the day of successful extubation, or until day 7 if necessary
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06499389