Comparison of Two Strategies for Setting Positive End-Expiratory Pressure in Acute Lung Injury/ Acute Respiratory Distress Syndrome (ExPress Study).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 768
- 试验地点
- 91
- 主要终点
- Mortality at 28 days
研究概览
简要总结
The aim of this multicenter randomized controlled trial is to compare the impact on mortality of patients mechanically ventilated for acute lung injury or acute respiratory distress syndrome of two strategies for setting end-expiratory pressure.
详细描述
Most patients suffering from acute lung injury or acute respiratory distress syndrome require mechanical ventilation. In this setting, positive end-expiratory pressure is used to improve arterial oxygenation. While the beneficial effect on clinical outcome of using low tidal volume is clearly proven, the best way to titrate PEEP is not known. Higher PEEP levels may better improve oxygenation and reduce ventilator-induced lung injury by reducing end-expiratory alveolar collapse but may also cause circulatory depression and aggravate lung injury from end-inspiratory overdistension. This trial compares the impact on outcome of two strategies for setting PEEP. In the "minimal alveolar distension" arm, PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H20). In the "maximal alveolar recruitment" arm, PEEP is set for a plateau pressure between 28 and 30 cm H20. A tidal volume of 6 ml/kg predicted body weight is used in the two arms. The goals for arterial oxygenation and PaCO2 are the same in the two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Mechanical ventilation through an endotracheal tube
- •Bilateral infiltrates consistent with pulmonary edema
- •PaO2/FiO2 < 300 mmHg
- •No clinical evidence of left atrial hypertension. If measured, pulmonary artery occlusion pressure < 18 mmHg
- •Criteria 1, 2 et 3 jointly present for less than 48 hours
- •Written informed consent obtained from the patient or surrogate
排除标准
- •Age < 18 years
- •Pregnancy
- •Expected duration of mechanical ventilation through an endotracheal tube < 48 hours
- •Participation in other trials within the previous 30 days
- •Increased intracranial pressure
- •Severe chronic respiratory disease
- •Morbid obesity (weight > 1kg/cm)
- •Sickle cell disease
- •Bone marrow transplant or chemotherapy-induced neutropenia
- •Extended burns (> 30 % total body surface area)
- •Severe chronic liver disease (Child-Pugh score C)
- •Pneumothorax
研究组 & 干预措施
Minimal alveolar distension
PEEP is set for a total PEEP (PEEP + intrinsic PEEP) between 5 and 9 cm H2O
干预措施: Setting of positive end-expiratory pressure (Device)
Maximal alveolar distension
PEEP is set for a plateau pressure between 28 and 30 cm H20
干预措施: Setting of positive end-expiratory pressure (Device)
结局指标
主要结局
Mortality at 28 days
时间窗: day 28
次要结局
- Mortality at 60 days(day 60)
- In hospital mortality(day 60)
- Proportion of patients alive and unassisted breathing at 28 days(day 28)
- Number of patients with pneumothorax(day 28)
- Ventilator free Days through day 28(day 28)
- Number of new organ failure before day 28(day 28)
- Number of days alive between the first positive "potential weanability test" and day 28(day 28)