Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

NCT06499389 · tracked via the Priya Life Science France tracker

Sponsor

Hospices Civils de Lyon

Phase

Not applicable

Started

2025-03-18

Last updated

2026-01-20

Condition(s) studied

Ventilator Weaning

Investigational drug(s) / intervention(s)

Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaningProtocolized standard-of-care respiratory physiotherapy

Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning: 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).

Protocolized standard-of-care respiratory physiotherapy: 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

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort — At Hour 24
PECF measured on the ventilator using its built-in flowmeter (PECF on unassisted coughing under mechanical ventilation). PECF is expressed in L/min.

Trial sites (3)

Facility	City	Region	Status
Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN	Lyon	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06499389 on ClinicalTrials.gov ↗ ← All trials in France