Comparison of a Patient Warming System Using a Forced-air, Non-compressible Under-body Mattress Versus a Regular Forced-air Underbody Mattress System During Pediatric Cardiac Catheterization
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Incidence of hypothermia
研究概览
简要总结
The study is a comparison of a patient warming system using a forced-air, non-compressible under-body mattress (Möck & Möck, Hamburg, Germany) versus a regular forced-air underbody mattress system during pediatric cardiac catheterization in 40 patients.
The hypothesis is, that the non-compressible mattress provides better warming with less incidence of perioperative hypothermia (Core temperature < 36 °C) and faster warming slope (°C / time). The study is prospective, randomized, controlled and single-blinded.
Inclusion criteria will be pediatric patients < 1 year of age without fever or a treatment of therapeutic hypothermia.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patient scheduled for cardiac catheterization (diagnostic and/or interventional)< 1 year old
排除标准
- •fever or therapeutic hypothermia
结局指标
主要结局
Incidence of hypothermia
时间窗: during surgery (1 - 6 hours)
次要结局
- Core Temperature Slope(during surgery (1 - 6 hours))
研究者
Oliver Kimberger
Assoc.Prof PD Dr. MSc
Medical University of Vienna