Impact of Intraoperative Protective One-lung Ventilation in Patients Undergoing Esophagectomy : a Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- cytokines of bronchoalveolar lavage
研究概览
简要总结
The purpose of this trial is to determine whether low tidal volume during intraoperative one-lung ventilation could decrease the incidence rate of postoperative acute lung injury compared to "normal" tidal volume.
详细描述
Large tidal volume are known risk factor of acute lung injury.Mechanical ventilation with low tidal volume has been shown to attenuate lung injuries in critically ill patients.Esophagectomy surgery need a relatively long time of one-lung ventilation. A normal tidal volume of two-lung ventilation should be a large one when exerted to one lung. We hypothesized that low tidal volume ventilation during one-lung ventilation could decrease incidence rate of postoperative acute lung injury and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of esophageal carcinoma and planned for esophagectomy
- •indication for one-lung ventilation
- •informed consent
- •ASA I~II
排除标准
- •NYHA III~IV
- •severe COPD
- •pulmonary fibrosis
- •any new pulmonary infiltrate on chest radiograph
- •preoperative acute infection suspected
- •altered liver function( Child-Pugh class B or moe)
- •acute or chronic renal failure
- •preoperative corticosteroid treatment during month before inclusion
结局指标
主要结局
cytokines of bronchoalveolar lavage
时间窗: 10 minutes before surgery ,at the end of surgery immediately
TNF-a,IL-1b,IL-6,IL-8 of BAL will be measured with enzyme-linked immunoassay,all markers will be reported with a unit of pg/ml
次要结局
- postoperative hospital days(after surgery up to the time when patient is discharged or dead，it is an average)
- incidence rate of acute lung injury(after surgery up to 28 days)
- incidence rate of surgical complications(after surgery up to 28 days)
- inhospital mortality(after surgery up to 28 days)
- Oxygenation Index(10 minutes before surgery,at the end of surgery immediately,12h after surgery)
- CT scan of chest(12 hours after the surgery)
研究者
Ming Zhong
department of anesthesiology and surgical intensive care unit
Shanghai Zhongshan Hospital