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

Civil Hospices of Lyon

Status: Enrolling

Conditions: Ventilator Weaning

Treatments: Procedure: Protocolized standard-of-care respiratory physiotherapy; Procedure: Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning

Study type: Interventional

Funder types: Other

Identifiers

NCT06499389

ID RCB (Other Identifier)

69HCL23_1275

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intensive instrumental and early respiratory physiotherapy

Experimental group

Description:

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

Treatment:

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

Protocolized standard-of-care respiratory physiotherapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Protocolized standard-of-care respiratory physiotherapy