The Efficacy of External Warming During Laparoscopic Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Intraoperative core-temperature decline
研究概览
简要总结
External warming is routinely used in general surgery to offset the deleterious effects of hypothermia. It entails deployment of a disposable, external heating blanket attached to a regulated hot-air pump.
The need for external warming in the morbidly obese population undergoing short laparoscopic procedures is unclear. If proven to be unnecessary, time and momentary costs could be lowered.
The study will compare core-temperature dynamics during laparoscopic bariatric procedures anticipated to last <2h. The study group will be left without a warming blanket while the control group will receive routine external warming. Post-anesthesia care unit (PACU) arrival temperature will also be recorded.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible for bariatric surgery
- •Surgery time estimated to be < 2 hours
排除标准
- •Previous abdominal surgeries (except laparoscopic cholecystectomies, appendectomies and hysterectomies+/-oophorectomies).
- •Surgery time estimated to be more than 2 hours
结局指标
主要结局
Intraoperative core-temperature decline
时间窗: Surgery duration, up to 2 hours from surgery start-time
Core-temperature will be continuously measured throughout surgery
Arrival temperature at post anesthesia care unit (PACU)
时间窗: arrival to recovery room, up to 2 h from surgery start-time
Core temperature upon arrival to recovery room
次要结局
- Intraoperative blood loss(Surgery duration, up to 2 hours from surgery start-time)
- Hypothermia events(3 hours from surgery start-time)
- Post operative complications(30 days postoperatively)
研究者
David Goitein MD
Director, Bariatric and Metabolic Surgery, Principal Investigator
Sheba Medical Center