Thermal Suit With Forced-air Warming in Breast Cancer Surgery: A Randomized Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Core temperature
研究概览
简要总结
The aim of this clinical investigation is to prove that the thermal suit with forced-air warming is more effective to prevent inadvertent intraoperative hypothermia than conventional warming methods. The study group will have the thermal suit from arriving to the hospital until to the ward after surgery. In the operating theatre forced-air warming device will be connected to the trouser legs of the thermal suit and the device will be turned on during surgery. The control group will have normal hospital clothes. Intraoperative warming will be managed with the warming mattress and a forced-air warming blanket. The primary endpoint is core temperature after arriving to the post-anaesthesia care unit.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •primary breast cancer surgery
- •unilateral resection or mastectomy with or without axillar lymphadenectomy
- •body mass index 25-40
排除标准
- •ASA > III
- •decreased mental status
- •inadequate Finnish language skills
- •other than general anaesthesia
结局指标
主要结局
Core temperature
时间窗: 1 hour
Core temperature after arriving to the post-anaesthesia care unit
次要结局
未报告次要终点