Prospective, Interventional Study Evaluating Heat Transfer With the Esophageal Cooling Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Mean heat transfer at cooling, kcal/h
研究概览
简要总结
An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each patient will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15-minute recovery break in between. The primary outcome will be heat transfer, determined from inflow and outflow temperatures and fluid flow rate for cooling and warming modes.
详细描述
The ECD is made with medical-grade silicone and has 3 ports; 2 coolant ports and a central port. The coolant ports of the ECD are connected to external heat exchanger while a third, central lumen simultaneously allows gastric decompression and drainage. The ECD can be inserted like a standard gastric tube.
The aim of this prospective, interventional study is to quantify heat transfer during warming and cooling using the Esophageal Cooling Device in anesthetized patients having non-cardiac surgery.
An esophageal heat exchange tube will be inserted in anesthetized surgical patients. Each will have 30 minutes of cooling (circulating fluid at 7 degrees C) and 30 minutes of warming (42 degrees C) with 15 -minute break in between; the order of the cooling and warming will be randomized. The primary outcome will be heat transfer, determined from inflow and outflow fluid temperatures and fluid flow rate assessed for both cooling and warming modes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Elective non-cardiac surgery;
- •Age 18-80 years;
- •Surgery expected to last >2 hours;
- •General anesthesia with endotracheal Intubation;
- •Volatile anesthesia;
- •BMI < 38 kg/m2;
- •ASA physical status 1-3.
排除标准
- •Weight < 45 kg;
- •Unstable blood pressure;
- •Known esophageal deformity or evidence of esophageal trauma or esophageal disease that in the opinion of the attending anesthesiologist precludes safe use of ECD.
结局指标
主要结局
Mean heat transfer at cooling, kcal/h
时间窗: 15-60 minutes after intubation during elective non-cardiac surgery
Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water
Mean heat transfer at warming, kcal/h
时间窗: 15-60 minutes after intubation during elective non-cardiac surgery
Heat transfer is calculated as difference between inflow and outflow temperatures, multiplied by flow and the specific heat of water
次要结局
未报告次要终点
研究者
d sessler
Chair Department of Outcomes Research
The Cleveland Clinic