Comparison of Lung Function in Patients After Lower Abdominal Surgery Exceeding 2hrs Under the Use of Laryngeal Mask vs. Endotracheal Tube for Airway Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- The change between pre- and postoperative forced expiratory volume in one second (FEV1) in lung function
研究概览
简要总结
We measure in this study lung function of 100 patients immediately after major lower abdominal surgery. We compare lung function, when either endotracheal intubation, or laryngeal masks are used for airway protection during surgery. The hypothesis is that the use of laryngeal masks is associated with less impairment of lung function in the immediate postoperative phase.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •increased risk of aspiration due to hiatal hernia, morbid obesity, or facial malformations
结局指标
主要结局
The change between pre- and postoperative forced expiratory volume in one second (FEV1) in lung function
时间窗: one day prior to surgery, 1 hour after surgery (recovery room), at day one after surgery
The lung function is quantified by using Spirometry and pulse oximetry. Spirometry is performed in a standardized way according to the recommendations of the American Thoracic Society (ATS) and European Respiratory Society (ERS)
次要结局
- Vital capacity (VC) measured by spirometry.(one day prior to surgery, i hour after after surgery (recovery room), at day one after surgery)
- Peak expiratory flow (PEF)(one day prior to surgery, one hour after surgery (recovery room) , at day one after surgery)
- Forced vital capacity (FVC)(one day prior to surgery, one hour after surgery (recovery room), at day one after surgery)
- mid-expiratory flow (MEF 25, 50, 75)(one day prior to surgery, one hour after surgery, at day one after surgery)
研究者
Prof. Dr. med. Daniel Reuter
Professor of Anesthesiology
Universitätsklinikum Hamburg-Eppendorf