Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- First successful central venous catheterization rate
研究概览
简要总结
The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •surgery under general anesthesia
- •require central venous catheterization
排除标准
- •central vein anomaly
- •hematoma in central vein
- •catheterization site infection
研究组 & 干预措施
Seldinger
Use a 23 gauge introducer needle for ultrasound-guided central venous catheterization
干预措施: Ultrasound (Device)
Seldinger
Use a 23 gauge introducer needle for ultrasound-guided central venous catheterization
干预措施: General anesthesia (Other)
Modified Seldinger
Use a 22 gauge Angiocath Plus catheter for ultrasound-guided central venous catheterization
干预措施: Ultrasound (Device)
Modified Seldinger
Use a 22 gauge Angiocath Plus catheter for ultrasound-guided central venous catheterization
干预措施: General anesthesia (Other)
结局指标
主要结局
First successful central venous catheterization rate
时间窗: Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes
次要结局
- First successful guide wire insertion rate(Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds)
- Time to guide wire insertion(Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds)
- Total time to central venous catheterization(Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes)
- Number of central vein puncture trial(up to 5 times, an expected average observation time of 30 seconds)
- Number of guide wire insertion trial(up to 5 times, an expected average observation time of 90 seconds)
- Time to first puncture of central vein(Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds)
- First successful central vein puncture rate(Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds)
研究者
Jin-Tae Kim
Associate professor
Seoul National University Hospital