跳至主要内容
临床试验/NCT04393844
NCT04393844进行中(未招募)不适用

Comparison of Success Rate of Catheter Insertion by the Presence of Obturator During Peripherally Inserted Central Venous Catheter in Pediatric Patient Undergoing General Anesthesia; Prospective Randomized Controlled Study

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2020年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
65
试验地点
2
主要终点
Success rate at one time

研究概览

简要总结

In pediatric patients under the age of 18 who undergo surgery under general anesthesia, when inserting peripherally inserted central venous catheterization, the group that inserts the catheter with the obturator and the group that inserts the catheter without the obturator is inserted into the appropriate position.

详细描述

In pediatric patients under the age of 18 who undergo surgery under general anesthesia, when inserting peripherally inserted central venous catheterization, the group that inserts the catheter with the obturator and the group that inserts the catheter without the obturator is inserted into the appropriate position.

There is no study confirming the probability of being placed in the central vein at a time when the catheter is inserted without the obturator, and there is no study comparing the clinical effect by dividing the case with the obturator and the obturator. In children, the blood vessels are small and there is a high probability that they cannot be located in the central vein when the peripheral vein is inserted.

Therefore, when a peripheral implanted central venous tube is inserted into a pediatric patient under general anesthesia under 18 years of age, the probability that the catheter is inserted without using an obturator will be located in the central vein at a time rather than using an obturator to insert the catheter. It could help pediatric patients to manage anesthesia and post-surgical care by reducing potential complications from using obturator.

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
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children under 18 years of age undergoing general anesthesia surgery at Seoul National University Hospital
  • ASA class I, II
  • If the legal guardian voluntarily consents after the explanation of the research

排除标准

  • Patients with a history of heart surgery or a history of congenital heart disease
  • Patients with hemodynamically unstable or massive bleeding and shock
  • Infection or systemic infection is suspected
  • Patients who have a blood clotting disorder
  • Abnormal cases when the vessel to be inserted is confirmed by ultrasound
  • the cases that the researcher determines that it is inappropriate

结局指标

主要结局

Success rate at one time

时间窗: confirmation through ultrasound procedure completed

Success rate to place into the central vein without additional treatment at one time

次要结局

  • other complication(procedure)
  • Number of insertion attempts(during procedure)
  • the location of catheter in case of the malposition at one time(confirmation through ultrasound procedure completed)
  • type of additional manipulation(during procedure)
  • final success rate(procedure)
  • Number of additional manipulation(during procedure)
  • final catheter location(procedure)

研究者

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

Hee-Soo Kim

Professor

Seoul National University Hospital

研究点 (2)

Loading locations...

相似试验