Clinical trial NCT06499389: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventilator Weaning
Keywords: critical care
mechanical ventilation
ventilatory weaning
peak cough expiratory flow
cough strength
mechanical cough
extubation
reintubation
chest physiotherapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort
timeFrame: At Hour 24
Secondary outcomes:
measure: Unassisted PECF after disconnection from mechanical ventilation during a voluntary coughing effort
timeFrame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
measure: Assisted PECF under mechanical ventilation
timeFrame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
measure: Semi-quantitative measurement of cough strength
timeFrame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
measure: Semi-quantitative measurement of cough strength
timeFrame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
measure: Semi-quantitative measurement of bronchial secretion quantity
timeFrame: At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7
measure: Rate of hemodynamic instability episodes
timeFrame: At Hour 24 and after every respiratory physiotherapy session
measure: Ratio of arterial oxygen partial pressure to fractional inspired oxygen (O2)
timeFrame: At Hour 24, Day 7
measure: Barotrauma complication rates
timeFrame: At Hour 24, Day 7
measure: Reintubation rate
timeFrame: At Hour 24, Day 7
measure: Number of days with invasive mechanical ventilation
timeFrame: Up to 60 days
measure: Ventilator-free days (VFD)
timeFrame: Up to 60 days
measure: Length of stay in intensive care unit
timeFrame: Up to 60 days
Other outcomes:
Locations:
city: Lyon
country: France
facility: Médecine Intensive - Réanimation, Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Département d'Anesthésie Réanimation - Médecine Intensive, Centre Hospitalier Lyon Sud
Study officials:
References: