Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients (PHYSIO WEAN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventilator Weaning
• Intervention / Treatment: Procedure: Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning; Procedure: Protocolized standard-of-care respiratory physiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria CLEYET, MSc; Phone Number: +33 04 26 10 94 93; Email: maria.cleyet@chu-lyon.fr
• Study Contact Backup: Name: Laurent BITKER, MD, PhD; Phone Number: +33 04 26 10 94 93; Email: laurent.bitker@chu-lyon.fr

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Médecine Intensive - Réanimation, Hôpital de la Croix Rousse
    • Contact: Maria CLEYET, MKDE, MSc); Phone Number: +33 07.88.20.68.86; Email: maria.cleyet@chu-lyon.fr
  • Lyon, France, 69495
    • Recruiting
    • Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud
    • Contact: Anaïs VISDOMINE, MKDE; Phone Number: +33 04.78.86.66.19; Email: anais.visdomine@chu-lyon.fr
  • France
    • Lyon, France, France, 69004
      • Not yet recruiting
      • Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN
      • Contact: Adrien ENEE, MKDE; Phone Number: +33 04 26 10 94 79; Email: adrien.enee@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive instrumental and early respiratory physiotherapy; Patients in this arm will receive instrumental and intensive respiratory physiotherapy strategy from inclusion to day 7, 3 times a day, before and after extubation. Instrumental physiotherapy will be protocolized and cough strength and efficacy of bronchial secretions clearance will be evaluated	Procedure: 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).
Active Comparator: Protocolized standard-of-care respiratory physiotherapy; Patients in this group will receive standardized and protocolized respiratory physiotherapy, i.e. 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.	Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unassisted PECF after disconnection from mechanical ventilation during a voluntary coughing effort	PECF measured by a spirometer without ventilation, either in intubated patients after disconnection from the ventilator, and in extubated patients by application of a naso-buccal mask connected to the spirometer. PECF is expressed in L/min.	At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Assisted PECF under mechanical ventilation	PECF measured by the spirometer during the application of mechanical (instrumental) cough assistance by connecting the spirometer between the intubation tube and the Cough Assist E70 in the intubated patient, or between the nasobuccal mask and the Cough Assist E70 in the extubated patient. PECF is expressed in L/min.	At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Semi-quantitative measurement of cough strength	Measurements of cough strength using a 6-level Likert scale (0-5) for intubated patients.	At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Semi-quantitative measurement of cough strength	Measurements of cough strength using a 4-level Likert scale (0-3) for extubated patients.	At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Semi-quantitative measurement of bronchial secretion quantity	Measurements of bronchial secretion quantity using a 5-level Likert scale (0 to 4). The intensity of bronchial secretion quantity is graded semi-quantitatively by observing the quantity of secretions mobilized and/or present in the patient's airways.	At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
Rate of hemodynamic instability episodes	Number of physiotherapy sessions with mean arterial pressure < 65 mmHg. Hemodynamic instability is defined as the appearance of mottles, a mean arterial pressure < 65 mm Hg and requiring urgent intervention.	At Hour 24 and after every respiratory physiotherapy session
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (O2)	Ratios of arterial partial pressure in O2 to inspired fraction in O2 measured on the ventilator (P/F ratio). In extubated, non-ventilated patients, fraction of inspired oxygen (FiO2) will be estimated using the following formula: 〖fraction inspired oxygen (FiO)〗_2 (%)=21+O2 flow (in L/min)× 3. Partial oxygen pressure (PaO2) is measured on arterial blood gas.	At Hour 24, Day 7
Barotrauma complication rates	Rate of barotraumatic complications. Thoracic (X-ray or computed tomography (CT) scan for pneumomediastinum and pneumothorax) or clinical examination (subcutaneous emphysema).	At Hour 24, Day 7
Reintubation rate	Rate of reintubation	At Hour 24, Day 7
Number of days with invasive mechanical ventilation	Time, in days, between inclusion and successful liberation from the ventilator	Up to 60 days
Ventilator-free days (VFD)	Time alive and free from invasive mechanical ventilation. A VFD of 0 is adjudicated to patients who died over that period, even if they were liberated from mechanical ventilation.	Up to 60 days
Length of stay in intensive care unit	Elapsed time, in days, between inclusion and ICU discharge	Up to 60 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: July 3, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: critical care; mechanical ventilation; chest physiotherapy; extubation; cough strength; reintubation; ventilatory weaning; peak cough expiratory flow; mechanical cough
• Other Study ID Numbers: 69HCL23_1275; ID RCB (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No