NCT00530491Unknown不适用
Prospective Randomized Controlled Trial to Reduce Morbidity and Mortality After Lung Surgery in Patients With FEV1 < 70% of Expected Value or < 1.5L
University of Ulm1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2007年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality
研究概览
简要总结
A fast track recovery program (thoracic epidural anesthesia, carbohydrate drink preoperative, early removal of chest tubes) is evaluated compared to conventional perioperative treatment (patient controlled analgesia, no carbohydrate drink preoperative) in patients with FEV1 < 70% of expected value or < 1.5L who undergo resections of the lung.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •resection of the lung
- •FEV1 <70% of expected value or below 1.5L
- •given written informed consent
排除标准
- •contraindication for epidural anesthesia
- •prio ipsilateral thoracotomy
- •chemotherapy <6 weeks prior to study enter
- •existing pneumonia (fever, elevated WCC, elevated CRP)
研究组 & 干预措施
1
Active Comparator
conventional perioperative management for lung surgery
干预措施: Fast track lung surgery (Procedure)
2
Experimental
fast track management for lung surgery
干预措施: Fast track lung surgery (Procedure)
结局指标
主要结局
pulmonary complications (air leak, atelectasis, pneumonia); lung function on pod 7; overall mortality
时间窗: 1 year
次要结局
- duration of ICU treatment(1 year)
研究者
研究点 (1)
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