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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Unassisted peak expiratory cough flow (PECF) under mechanical ventilation during a voluntary coughing effort
时间窗: 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.
次要结局
- Semi-quantitative measurement of bronchial secretion quantity(At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
- Rate of hemodynamic instability episodes(At Hour 24 and after every respiratory physiotherapy session)
- Ratio of arterial oxygen partial pressure to fractional inspired oxygen (O2)(At Hour 24, Day 7)
- 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)
- Semi-quantitative measurement of cough strength(At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
- Assisted PECF under mechanical ventilation(At Hour 24, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
- Barotrauma complication rates(At Hour 24, Day 7)
- Reintubation rate(At Hour 24, Day 7)
- Number of days with invasive mechanical ventilation(Up to 60 days)
- Ventilator-free days (VFD)(Up to 60 days)
- Length of stay in intensive care unit(Up to 60 days)