A RCT of Mechanical Ventilation, Directed by Esophageal Pressure Measurements, in Patients With Acute Lung Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Oxygenation as measured by the PO2/FiO2 (P/F) ratio
研究概览
简要总结
The purpose of this study is to see whether esophageal pressure (PES) measurements will allow the investigators to choose the best method of mechanical ventilation in patients with acute lung injury (ALI).
详细描述
The current standard of practice for ventilating patients with acute respiratory distress syndrome (ARDS) is the ARDSnet protocol (N Engl J Med 2000; 342:1301-1308) which has been shown to improve survival by limiting tidal volumes and thus preventing over distention of the lungs. However, the lungs can also be damaged by under-inflation during mechanical ventilation, and current practice ignores the effects of chest wall compression of the lungs, which can cause under-inflation. The investigators have observed that a fraction of critically ill patients with apparent ARDS have lung function abnormalities caused by extrinsic compression which can be estimated by PES measurements. Changing ventilator settings to apply normal physiological pressure to the lung has been beneficial in many such patients. This protocol will formally test the clinical utility of PES measurements in patients with ARDS.
This is a randomized controlled trial of therapy directed by esophageal balloon measurements (PES) versus therapy directed by ARDSnet protocol, the current standard of care.
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 ALI/ARDS according to the International Consensus Conference criteria:
- •PaO2/FiO2 ratio < 300
- •Acute onset
- •Bilateral infiltrates on chest radiography
- •PAOP < 18 or, in patients without a pulmonary artery catheter, no other evidence of abnormal cardiac function
排除标准
- •Patients with esophageal varices
- •Patients with esophageal trauma
- •Patients with recent esophageal surgery
- •Patients with coagulopathy (platelets < 80k or International Normalized Ratio [INR]> 2 )
- •Post transplant patients
- •Patients with significant broncho-pleural fistula
结局指标
主要结局
Oxygenation as measured by the PO2/FiO2 (P/F) ratio
时间窗: 72 hours from enrollment
次要结局
- Ventilator free days(At 28 days)
- Markers of inflammation(In first 72 hours)
- Mortality(At 28, 90 and 180 days)
- Length of stay(Hospital and ICU)
研究者
Daniel Talmor
Edward Lowenstein Professor of Anaesthesia
Beth Israel Deaconess Medical Center