Efficacity and Safety of Mechanical Insufflation-exsufflation on Intubated and Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Mucus volume retrieved
研究概览
简要总结
Critically ill and intubated patients on mechanical ventilation (IMV) often present retention of respiratory secretions, increasing the risk of respiratory infections and associated morbidity. Endotracheal suctioning (ETS) is the main strategy to prevent mucus retention, but its effects are limited to the first bronchial bifurcation.
Mechanical in-exsufflation devices (MI-E) are a non-invasive chest physiotherapy (CPT) technique that aims to improve mucus clearance in proximal airways by generating high expiratory flows and simulating cough. Currently there are no studies that have specifically assessed the effects of MI-E in critically ill and intubated patients. Thus, the aims of this study are to evaluate efficacy and safety of MI-E to improve mucus clearance in critically ill and intubated patients.
详细描述
Controlled randomized, cross-over, single blind trial conducted at University Hospital of Bordeaux (France).
Inclusion criteria: Patients (>18 yo) intubated [internal diameter (ID) 7 to 8], sedated [Richmond Agitation Sedation Scale (RASS) -3 to -5], connected to IMV at least 48 h and expected IMV of at least 24h.
Exclusion criteria: Lung disease or pulmonary parenchyma damage, respiratory inspired fraction of oxygen (FiO2) >60% and/or positive end-expiratory pressure (PEEP) > 10 centimetres of water (cmH2O) and/or hemodynamic instability (mean arterial pressure (MAP) < 65 millimetres of mercury (mmHg) although use of vasopressors] , hemofiltered patients through a central jugular catheter, patients on strict dorsal decubitus by medical prescription, and high respiratory infectious risk.
Design: All patients will receive CPT followed by ETS twice daily. However, patients will randomly receive in one of the sessions an additional treatment of MI-E before ETS. MI-E treatment consists in 4 series of 5 in-expiratory cycles at +/- 40 cmH2O, 3 and 2 sec of inspiratory-expiratory time and 1 sec pause between cycles.
Variables: Mucus clearance will be assessed through wet volume of suctioned sputum through a suction catheter connected to a sterile collector container. Pulmonary mechanics will be measured before, after and 1 h post-intervention through a pneumotachograph (PNT). Peak expiratory flow (PEF) generated by MI-E will be continuously measured through a PNT. Hemodynamic measurements will be recorded before, after and 1 h post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old.
- •Patents endotracheally intubated (tubes between 7mm and 8mm of internal diameter).
- •Invasive mechanical ventilation > 48h
- •Invasive mechanical ventilation expected > 24h
- •RASS between -3 and -5
排除标准
- •Lung disease with pulmonary parenchyma injury or diseases where mechanical insufflation-exsufflation use is not recommended (eg: emphysema, pneumothorax, pneumomediastinum, hemoptyses, airway instability, acute barotrauma).
- •Hemofiltered patients through a central jugular catheter.
- •Respiratory instability (FiO2) >60% and/or (PEEP) > 10cmH2O, and/or hemodynamic instability (MAP) < 65mmHg although use of vasopressors)] instability
- •Patients on strict dorsal decubitus by medical prescription.
- •High risk infection patients (eg: tuberculosis, H1N1) that cannot be disconnected from IMV.
研究组 & 干预措施
Chest physiotherapy techniques
Manual chest physiotherapy techniques applied
干预措施: Chest physiotherapy techniques (Other)
Chest physiotherapy techniques + Mechanical in-exsufflation
Mechanical insufflation-exsufflation in addition to manual chest physiotherapy techniques
干预措施: Mechanical insufflation-exsufflation (Device)
结局指标
主要结局
Mucus volume retrieved
时间窗: Immediately after treatment
respiratory secretions (ml) will be suctioned by a suctioning catheter connected to a sterile collector container
次要结局
- Complications(Through study completion)
- Pulmonary mechanics(1 hour after treatment)
- Hemodynamic measurements(1 hour after treatment)
- Arterial blood gases(1 hour after treatment)
研究者
Roberto Martinez Alejos
RPT
University Hospital, Bordeaux