The Role of Diaphragm Electromyography (EMG) Guided Mechanical Ventilation on Respiratory Physiology in Mechanically Ventilated Patients With Acute Respiratory Distress Syndrome (ARDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Pressure-time product of the diaphragm
研究概览
简要总结
The purpose of this study is to demonstrate that mechanical ventilation guided by the diaphragm EMG signal (also know as neurally adjusted ventilatory assist [NAVA]) is superior compared to pressure support and pressure control ventilation.
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
- 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
- •intubated, mechanically ventilated patients
- •meeting criteria for ARDS
- •mean arterial blood pressure > 65 mmHg (with or w/o vasopressors)
排除标准
- •pregnancy
- •increased intracranial pressure
- •contra-indication naso-gastric tube
- •diagnosed neuro-muscular disorder
- •recent (<12 hours) use of muscle relaxants
- •exclusion from sedation interruption protocol as used in our institution
- •open chest or- abdomen
- •very high inspiratory flow rate during supported ventilation
- •inability to obtain informed consent
结局指标
主要结局
Pressure-time product of the diaphragm
时间窗: average of last 15 minutes of each study arm
The pressure-time product of the transdiaphragmatic pressure (Pdi) during inspiration is obtained for each breath by multiplying the corresponding mean inspiratory Pdi signal above the end-expiratory baseline by the inspiration time. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
Patient - ventilator asynchrony index
时间窗: average of last 15 minutes of each study arm
Ventilator asynchrony is determined as the sum of the triggering and cycling-off delays per breath, expressed as a percentage of the total breath duration. The trigger delay is measured as the time difference between the onset of neural inspiration and the ventilator inspiratory flow, and the cycling delay as the time difference between the end of neural inspiration and the end of ventilator inspiratory flow. Breath-by-breath data are ensemble-averaged over the last 15 minutes of each study arm.
次要结局
- Transpulmonary pressure(average of last 15 minutes of each study arm)
- Transdiaphragmatic pressure(average of last 15 minutes of each study arm)
- Oxygenation index(at the end of each study arm)
- Dead space ventilation(average of last 15 minutes of each study arm)
研究者
Leo Heunks
MD PhD
University Medical Center Nijmegen