NCT05349734已完成不适用
Comparison of Upper Body and Full Underbody Forced Air Blanket for Maintaining Normothermia in Pediatric Patients Undergoing Cardiovascular Interventions Under General Anesthesia: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- hypothermia
研究概览
简要总结
The aim of this study is to compare the underbody blanket and overbody blanket for forced air warming to maintain normothermia in pediatric patients undergoing cardiovascular interventions under general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pediatric patients under 15 years of age who are scheduled for cardiovascular interventions in angioroom
排除标准
- •anticipated operating time < 1 hour
- •body surface area that exposured by drape < 30% of total body surface area
- •BMI > 30
- •corrected age < 40 weeks
- •preoperative body temperature is higher than 37℃ or less than 35.5℃
- •patients with skin disease
- •history of malignant hyperthermia
- •patients who cannot use esophageal stethoscope
结局指标
主要结局
hypothermia
时间窗: intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room)
time weighted average out of normothernia (body temperature over 37.5℃ and under 36.5℃) in intraoperative period
次要结局
- hyperthermia(intraoperative period (from the time when patient enters the operating room to the time when patient exits the operating room))
- shivering score at post-anesthesia care unit(15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit)
- thermal comfort scale(15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit)
- clinical outcomes after the surgery(5 days after the surgery)
- patient satifisfaction at post-anesthesia care unit(15 minutes, 30 minutes, 45 minutes, 60 minutes after entering the post-anesthesia care unit)
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital
研究点 (1)
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