Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

Official title

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

Overview

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.

Interventions

• 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).
• 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

Primary outcome measures

• Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort [Time frame: At Hour 24]

Secondary outcome measures (12)

• Unassisted PECF after disconnection from mechanical ventilation during a voluntary coughing effort [Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7]
• Assisted PECF under mechanical ventilation [Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7]
• Semi-quantitative measurement of cough strength [Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7]
• Semi-quantitative measurement of cough strength [Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7]
• Semi-quantitative measurement of bronchial secretion quantity [Time frame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7]
• Rate of hemodynamic instability episodes [Time frame: At Hour 24 and after every respiratory physiotherapy session]
• Ratio of arterial oxygen partial pressure to fractional inspired oxygen (O2) [Time frame: At Hour 24, Day 7]
• Barotrauma complication rates [Time frame: At Hour 24, Day 7]
• Reintubation rate [Time frame: At Hour 24, Day 7]
• Number of days with invasive mechanical ventilation [Time frame: Up to 60 days]
• Ventilator-free days (VFD) [Time frame: Up to 60 days]
• Length of stay in intensive care unit [Time frame: Up to 60 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 3 centers

• Service d'Anesthésie et Réanimation, Hôpital de la Croix Rousse, GHN — Lyon
• Médecine Intensive - Réanimation, Hôpital de la Croix Rousse — Lyon
• Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud — Lyon

Identifiers

NCT: NCT06499389 · 69HCL23_1275 · ID RCB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗