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临床试验/NCT03530618
NCT03530618已完成不适用

Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2018年9月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
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 flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.

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
None

入排标准

年龄范围
— 至 6 Months(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

Flexible tip straight guidewire

Experimental

干预措施: Flexible tip straight guidewire (Device)

J-tip guidewire

Experimental

干预措施: J-tip (Device)

结局指标

主要结局

First successful central venous catheterization rate

时间窗: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes

次要结局

  • Time to first puncture of central vein(Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds)
  • Time to guide wire insertion(Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds)
  • Total time to central venous catheterization(Interval between skin penetration of the needle 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)
  • 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)
  • First successful guide wire insertion rate(Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Tae Kim

professor

Seoul National University Hospital

研究点 (1)

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