Hemodynamic Impact of Low and High Tidal Volume Mechanical Ventilation in Acute Lung Injury (ALI)/Acute Respiratory Distress Syndrome (ARDS) Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- cardiac index
研究概览
简要总结
Mechanical ventilation with low tidal volume (about 6 ml.kg-1) reduces mortality in ALI/ARDS patients respect to high tidal volume ventilation (about 12 ml.kg-1).
This finding is usually explained by alveolar tidal overdistension associated to high tidal volume. Stretch-induced lung injury may trigger a cytokine-mediated inflammatory response. This may contribute to the development of systemic inflammatory response and multiple system organ failure and death.
High tidal volume strategies might affect organ function by pathways not mediated by inflammatory response.
It is well recognized the inverse relationship between tidal volume and cardiac output during mechanical ventilation. Nevertheless there are no clinical studies about cardiac output changes induced by low (6 ml.kg-1) and high tidal volume (12 ml.kg-1) in ALI/ARDS patients.
The study hypothesis is that high tidal volume ventilation reduces cardiac output in ALI/ARDS patients respect to low tidal volume strategy. Thereafter reduced hemodynamic impact could explain beneficial effect of low respect to high tidal volume ventilation.
If study hypothesis is confirmed, other studies should define the main cause of mortality reduction related to low tidal volume strategies and if appropriate hemodynamic monitoring and support should be required when low tidal volume strategies are harmful (i.e. traumatic brain injury).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Outcomes Assessor)
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
- •diagnosis of ARDS/ALI
排除标准
- •mean arterial pressure lower than 65 mmHg
- •beginning or change of vasoactive agents infusion rate in the last 2 hours
结局指标
主要结局
cardiac index
时间窗: after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1
次要结局
- oxygen delivery(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)
- oxygen consumption(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)
- mixed venous saturation(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)
- relationship between partitioned elastance (lung and chest wall) and cardiac index difference between ventilation with tidal volume 6 and 12 ml.kg-1(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)
- abdominal perfusion pressure (mean arterial pressure minus abdominal pressure)(after 30 minutes of mechanical ventilation with tidal volume of 6 or 12 ml.kg-1)