Instrumental Respiratory Physiotherapy in Difficult-to-wean ICU Patients
NCT Number: NCT06499389
Acronym: PHYSIO WEAN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Ventilator Weaning
Interventions: PROCEDURE: Systematic and early intensive instrumental respiratory physiotherapy for patients undergoing difficult ventilatory weaning|PROCEDURE: Protocolized standard-of-care respiratory physiotherapy
Sponsor: Hospices Civils de Lyon
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-11

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.

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