Tomodensitometric Study of Pulmonary Effects of Intrapulmonary Percussive Ventilation in ARDS Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change from baseline (H0) in volume of overinflated lung at H1
研究概览
简要总结
The study is intended to elucidate the pulmonary effects of Intrapulmonary Percussive Ventilation (IPV) with VDR4 ventilator of patients with ARDS, using computed tomography (CT).
详细描述
Prospective clinical study in ICU of ventilated patients with ARDS. The morphologic pulmonary effects of IPV with VDR4 are not known to the investigators' knowledge.
The main aim is to quantify recruited, normally aerated and overinflated parts of the lungs after a 1 hour treatment with IPV.
Patients with ARDS (focal and non focal) consecutively admitted to the investigators' ICU are enrolled after informed consent.
Patients are intubated and ventilated with Servo-I (GE) and ventilation is optimized according to ARDS-network recommandations.
A first thoracic CT-scan is performed with ICU ventilator and then the patient is ventilated with VDR4 during 1 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ventilated more than 48 h
- •Sedated patients
- •ARDS moderate or severe (Berlin 2012)
- •Patients who have given their consent or his family
- •Patients aged between 18 and 85 years
排除标准
- •Pregnant ou lactating women
- •Hemodynamic instability
- •Chronic respiratory insufficiency.
- •Pneumothorax
- •Fistulae bronchopleural
结局指标
主要结局
Change from baseline (H0) in volume of overinflated lung at H1
时间窗: at Hour 0(just before Intrapulmonary Percussive Ventilation) and Hour 1(just after Intrapulmonary Percussive Ventilation)
次要结局
- Blood pressure(at day 1 (every 10 min between H0 and H1))
- Arterial blood gaz(at day 1 ((every 10 min between H0 and H1))
- Volume of normally aerated lung(at Hour 0 (just before Intrapulmonary Percussive Ventilation ) and Hour 1 (just after Intrapulmonary Percussive Ventilation))
- Evolution of catecholamine doses (µg/Kg/min)(at day 1 (every 10 min between H0 and H1))
- Volume of recruited lung(at day 1 (between H0 and H1))
- Heart rate(at day 1 ((every 10 min between H0 and H1))