Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06499389
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-03
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Study Start: 2024-09
• Primary Completion: 2026-09
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocolized standard-of-care respiratory physiotherapy	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.
Intensive instrumental and early respiratory physiotherapy	Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Semi-quantitative measurement of bronchial secretion quantity	At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7	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.
Rate of hemodynamic instability episodes	At Hour 24 and after every respiratory physiotherapy session	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.
Ratio of arterial oxygen partial pressure to fractional inspired oxygen (O2)	At Hour 24, Day 7	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.
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	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.
Semi-quantitative measurement of cough strength	At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7	Measurements of cough strength using a 4-level Likert scale (0-3) for extubated patients.
Assisted PECF under mechanical ventilation	At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7	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.
Barotrauma complication rates	At Hour 24, Day 7	Rate of barotraumatic complications. Thoracic (X-ray or computed tomography (CT) scan for pneumomediastinum and pneumothorax) or clinical examination (subcutaneous emphysema).
Reintubation rate	At Hour 24, Day 7	Rate of reintubation
Number of days with invasive mechanical ventilation	Up to 60 days	Time, in days, between inclusion and successful liberation from the ventilator
Ventilator-free days (VFD)	Up to 60 days	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.
Length of stay in intensive care unit	Up to 60 days	Elapsed time, in days, between inclusion and ICU discharge