Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

NCT06499389 | Recruiting

• 2 other identifiers: 69HCL23_1275ID RCB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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 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

Ventilator Weaning

Keywords

critical care; mechanical ventilation; ventilatory weaning; peak cough expiratory flow; cough strength; mechanical cough; extubation; reintubation; chest physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Unassisted PECF after disconnection from mechanical ventilation during a voluntary coughing effort

  At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

• Assisted PECF under mechanical ventilation

  At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

• Semi-quantitative measurement of cough strength

  At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

• Semi-quantitative measurement of cough strength

  At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

• Semi-quantitative measurement of bronchial secretion quantity

  At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7

Study Arms (2)

Intensive instrumental and early respiratory physiotherapy

EXPERIMENTAL

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

Protocolized standard-of-care respiratory physiotherapy

ACTIVE COMPARATOR

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

Interventions

Protocolized standard-of-care respiratory physiotherapy PROCEDURE

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

Protocolized standard-of-care respiratory physiotherapy

Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning PROCEDURE

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).

Intensive instrumental and early respiratory physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN

Lyon, France, 69004, France

NOT YET RECRUITING

Médecine Intensive - Réanimation, Hôpital de la Croix Rousse

Lyon, 69004, France

RECRUITING

Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud

Lyon, 69495, France

RECRUITING

Central Study Contacts

Maria CLEYET, MSc

CONTACT

04 26 10 94 93; maria.cleyet@chu-lyon.fr

Laurent BITKER, MD, PhD

CONTACT

04 26 10 94 93; laurent.bitker@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 12, 2024
• Study Start: March 18, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

FR (3)