Effect of Local Warming for Arterial Catheterization in Pediatric Cardiac Surgery: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- first-attempt success rate of arterial catheterization
研究概览
简要总结
The increase in internal diameter (ID) and cross-sectional area (CSA) may facilitate better arterial catheterization. Since an increase in body temperature can cause peripheral vasodilation, we aimed to determine if local warming of the radial artery (RA) catheterization site could improve the success rate of catheterization in pediatric patients.
详细描述
This randomized, controlled study enrolls 126 pediatric patients aged ≤ 2 years who were scheduled for heart surgery. They are randomized into non-warming (C) and warming (W) groups. After induction, the baseline artery ultrasonography images are collected. In the warming group (W), local warming is applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. The primary outcome is the first-attempt success rate. The secondary outcomes included the ID and CSA of the artery and overall complications.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≤ 2 years
- •cardiac surgery with peripheral artery catheterization
排除标准
- •unstable vital signs
- •pre-existing arterial catheter (exception of umbilical artery catheterization)
研究组 & 干预措施
Non-warming group (C)
After induction, the baseline artery ultrasonography images are collected for the internal diameter and cross-sectional area of the artery. In the non-warming group (C), local warming is not applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. Then, arterial catheterization is applied.
Warming group (W)
In the warming group (W), local warming is applied on the catheterization site. Before catheterization, the artery ultrasonography images are collected. Then, arterial catheterization is done.
干预措施: local warming (Procedure)
结局指标
主要结局
first-attempt success rate of arterial catheterization
时间窗: baseline, imediate after arterial catheterization
The first-attempt success rate of pediatric peripheral arterial catheterization in the non-warming group, or warming group
次要结局
- internal diameter (ID) and cross-sectional area (CSA)(baseline, imediate after arterial catheterization in the non-warming group, or warming group)
研究者
Kim Hee Young
Fund assistant professor
Pusan National University Yangsan Hospital