Status:
RECRUITING
Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Ventilator Weaning
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
- Failure of 7 or more SBT at time of eligibility
- 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
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06499389
Start Date
March 18 2025
End Date
May 1 2027
Last Update
March 20 2025
Active Locations (2)
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1
Médecine Intensive - Réanimation, Hôpital de la Croix Rousse
Lyon, France, 69004
2
Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud
Lyon, France, 69495