Pilot Clinical Study on Patient-Specific Adjustment of Ventilator Settings Using Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Stress
研究概览
简要总结
First clinical application of an algorithm for individual adjustment of ventilator settings using electrical impedance tomography.
详细描述
In patients suffering from early Acute Respiratory Distress Syndrome (ARDS), an algorithm for individual adjustment of positive end-expiratory pressure and tidal volume will be applied. After optimization of ventilator settings according to the ARDS Network protocol, lung stress and strain, driving pressure, respiratory system compliance (Crs), regional ventilation delay and PaO2 / FiO2 ratio will be recorded. Subsequently, ventilator settings will be adjusted using an algorithm aiming at recruitment and avoiding tidal recruitment and overdistension using electrical impedance tomography (EIT). After 4 hours of EIT-based optimization ventilator settings, lung stress and strain, driving pressure, respiratory system compliance (Crs), regional ventilation delay and PaO2 / FiO2 ratio will be recorded again. The results will be compared to the ARDS Network approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Acute Respiratory Distress Syndrome (according to Berlin Definition)
排除标准
- •Hemodynamic Instability (defined as mean arterial pressure < 65 mmHg OR heart rate < 40 / min OR heart rate > 150 / min OR cardiac index < 2.0 l/min/m^2 DESPITE adequate fluid resuscitation and adequate therapy with inotropes and / or vasopressors)
- •Thoracic burns or severe skin injuries
- •High frequency oscillatory ventilation
- •Pregnancy
- •Severe chronic obstructive pulmonary disease (GOLD IV)
- •Esophageal varices > grade I
- •Esophageal resection
- •Invasive ventilation prior to study inclusion for more than 72 hours after onset of ARDS
- •Inspiratory oxygen requirement > 80%
结局指标
主要结局
Stress
时间窗: 4 hours
Percentage of patients with lung stress (defined as trans-pulmonary pressure during an end-inspiratory hold) below 27 mbar after 4 hours of adjustment of ventilator settings with the algorithm.
Strain
时间窗: 4 hours
Percentage of patients with lung strain (defined as end-inspiratory lung volume divided by functional residual capacity) below 2.0 after 4 hours of adjustment of ventilator settings with the algorithm.
次要结局
- Compliance(4 hours)
- Standard Deviation of regional ventilation delay(4 hours)
- Driving Pressure(4 hours)
- PaO2 / FiO2 Ratio(4 hours)
研究者
Norbert Weiler
Prof. N. Weiler
University Hospital Schleswig-Holstein