Randomized Controlled Pilot Study of Positive End-Expiratory Pressure (PEEP) in Acute Respiratory Distress Syndrome(ARDS): Individualized According to the Best Compliance or Fixed According to Fraction of Inspired Oxygen (FiO2) Applied
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Arterial Oxygenation
研究概览
简要总结
Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters of water (cmH2O), to compare two different methods of selecting the level of Positive End-Expiratory Pressure (PEEP) to be applied: according to fraction of inspired oxygen (FiO2) needed or individualized according to the best compliance. Primary objective was evolution of arterial oxygenation during the 28 days. Secondary objectives were to measure its effects on hemodynamic parameters, 28-day mortality, number of ventilator-free days at day 28, Intensive Care Unit (ICU) and hospital stay, number of multiple-organ dysfunction-free days and a multivariate analysis of 28 day-mortality.
详细描述
In patients with Acute Respiratory Distress Syndrome the use of Positive End-Expiratory Pressure (PEEP) avoids atelectrauma, improves gas exchange and induces alveolar recruitment.Although it has side effects as inducing alveolar overdistension and circulatory depression.
There are several methods to determine the level of PEEP to be applied. We conducted a study to test the hypothesis that an individualized level of PEEP, set et the best compliance, when compared with a fixed level according to the fraction of inspired oxygen applied, improves oxygenation and reduces mortality rate at 28 days.
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
- •Patients with Acute Respiratory Distress Syndrome (ARDS) according to the American-European Consensus Conference definition, after 24 hours under mechanical ventilation.
排除标准
- •Younger than 18-year-old
- •Pregnancy
- •Neuromuscular diseases
- •Intracranial hypertension. Head trauma
- •Left ventricular dysfunction
- •Mechanical ventilation for more than 72 hours
- •Previous barotrauma
- •Patients with terminal stage of an illness and high risk of mortality within 90 days
- •Patients who refused to consent to the study
研究组 & 干预措施
Compliance-guided PEEP group
Positive End-Expiratory Pressure(PEEP) level was set daily, according to the method described by Suter in 1978. Static compliance (Cst) was calculated at different levels of PEEP at a constant tidal ventilation of 6-8 ml/kg of predicted body weight. Cst was determined by dividing tidal volume by the difference between the pressure at the end of inflation hold and the PEEP. The maximum value of Cst in individual patients was considered as the best PEEP.
干预措施: Positive End-expiratory Pressure (PEEP) (Other)
FiO2-driven-PEEP group
PEEP was set based on the patient fraction of inspired oxygen (FiO2) according to the Positive End-Expiratory Pressure(PEEP) strategy reported in 2000:"Ventilation with lower tidal volumes as compared with traditional tidal volumes for acute lung injury and the acute respiratory distress syndrome. The Acute Respiratory Distress Syndrome Network".
干预措施: Positive End-expiratory Pressure (PEEP) (Other)
结局指标
主要结局
Arterial Oxygenation
时间窗: 28 days
Evolution of arterial oxygenation during the 28 days after study randomization
次要结局
- Mortality(28 days)
- Number of ventilator-free days at day 28(28 days)
- multivariate analysis of mortality(28 days)