Actively Recruiting
Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
Led by Hospices Civils de Lyon · Updated on 2026-01-20
50
Participants Needed
3
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 6 2 on the 6-point Likert scale
You will not qualify if you...
- Recent brain injury (less than 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%, oxygen saturation < 88%, positive end-expiratory pressure > 5 cmH2O or respiratory rate 6 35 min-1
- Vasopressor catecholamine dose > 0.5 bcg/kg/min
- Tracheostomized patient
- Undrained pneumothorax
- Pulmonary emphysema
- Uncontrolled hemoptysis
- Surgery less than 3 months ago on esophagus or ear, nose and throat area
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN
Lyon, France, France, 69004
Not Yet Recruiting
2
Médecine Intensive - Réanimation, Hôpital de la Croix Rousse
Lyon, France, 69004
Actively Recruiting
3
Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud
Lyon, France, 69495
Actively Recruiting
Research Team
M
Maria CLEYET, MSc
CONTACT
L
Laurent BITKER, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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