NCT00711867已完成3 期
Intraoperative Warming: Comparison of Performance of the Dynatherm Medical vitalHeat™ Temperature Management System (vH2) and the Arizant Bair Hugger System
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Sublingual Temperature.
研究概览
简要总结
The sublingual (under the tongue) core temperature within 10 minutes of arrival in the post anesthesia care unit (PACU) for patients warmed with the Dynatherm vitalHeat2 (VH2) System under general anesthesia for total knee arthroplasty will be equivalent to that of patients 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
- Prevention
- 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
- •Initial total knee arthroplasty.
- •Expected duration of surgery at least 2 hours.
- •General anesthesia.
- •American Society of Anesthesiologists (ASA) classification I-III.
- •Age >= 18 years.
排除标准
- •Skin abrasion at the device application site.
- •History of peripheral vascular disease.
- •History of allergic skin conditions of the upper extremities.
- •History of malignant hyperthermia.
结局指标
主要结局
Sublingual Temperature.
时间窗: Within 10 minutes of arrival in PACU
次要结局
未报告次要终点
研究者
研究点 (2)
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