Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHEAT Temperature Management System(vH2)With the Arizant Bair Hugger System
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Compare esophageal temperatures after 60 minutes of warming with each system
研究概览
简要总结
Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal. To minimize this drop in body temperature, different types of body warming products are used during surgery. This study is designed to compare the the temperatures of people under general anesthesia after 60 minutes of warming with each product. The study hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will decrease less in the first 60 minutes of warming time than people warmed with the Arizant Bair Hugger System.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pts undergoing orthopedic surgical procedure with expected duration 2-3 hrs
- •General anesthesia required
- •ASA physical status I-III
排除标准
- •General anesthesia plus epidural anesthesia required
- •Skin abrasions/trauma to extremity selected as application site
- •History of peripheral vascular disease
- •History of malignant hyperthermia
- •Unwilling/unable to give consent
研究组 & 干预措施
1
Use of the Dynatherm Medical vitalHEAT vH2 Temperature Management System to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia.
干预措施: vitalHEAT vH2 Temperature Management System (Device)
2
Use of the Arizant Healthcare Bair Hugger Temperature Management System & Bair Hugger Upper Body Blanket to warm patients undergoing orthopedic surgical procedures with an expected duration 2-3 hours and requiring general anesthesia.
干预措施: Arizant Healthcare Bair Hugger Temperature Management System (Device)
结局指标
主要结局
Compare esophageal temperatures after 60 minutes of warming with each system
时间窗: 60 minutes of patient warming
次要结局
- Compare esophageal temperature trends during surgical procedures(Every 15 minutes during procedure)
- Compare sublingual temperatures of patients in PACU(Within 10 minutes of arrival in PACU)