One-Lung Ventilation in Morbidly Obese Patients:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of Participants in Which the Tube Was Successfully Positioned at First Attempt
研究概览
简要总结
The purpose of this study is to determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery.
详细描述
The purpose of the study is to compare a double lumen tube versus the standard single-lumen tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung ventilation during surgery. The objects is to determine which device is best for intubation and is most effective in terms of optimal positioning of the device, of lung collapse, and quality of lung isolation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation.
- •Subject is >18 years of age.
- •Subject's BMI > 35.
排除标准
- •Subject < 18 years of age.
- •Subject's BMI < 35.
结局指标
主要结局
Number of Participants in Which the Tube Was Successfully Positioned at First Attempt
时间窗: This data measure was occurred during surgery.
Number of participants in each group in which the tube was successfully positioned at first attempt
Time Taken for Endotracheal Tube Placement Procedure.
时间窗: This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.
For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube. Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope.
次要结局
- Number of Participants With Successful Reinflation(This occurred during surgery.)
- Effectiveness of Lung Collapse(This measure occured during surgery just after intubation.)
- Time Required to Collapse the Lung(This measurement occurred during surgery.)
- Mean Intraoperative Oxygenation During One-lung Ventilation(This measure occured during surgery.)
研究者
Javier H Campos
Professor in Anesthesia
University of Iowa