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临床试验/NCT03134560
NCT03134560已完成不适用

Comparison Between Using Vein Display Instrument and Without Using Vein Display Instrument for Successful Intravenous Cannulation in Pediatric Patients

Indonesia University2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
2
主要终点
Successful first vein cannulation attempt

研究概览

简要总结

This study aims to compare intravenous cannulation success rate between using vein display instrument and without using vein display instrument in pediatric patients.

详细描述

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Parents' subjects were given informed consent before enrolling the study. After doing asepsis and antisepsis procedure and putting on the tourniquet the first group would get intravenous cannulation without vein displaying instrument. While for the second group, after doing asepsis procedure and tourniquet was put on, a vein display instrument was used to choose the vein. Intravenous cannulation was done after antiseptic procedure. After blood dripped out of the cannula, cannula was connected to the infusion set. Evaluation was done to assess vein route establishment, canulation attempt number and swelling. Data recorded were analyzed using Statistical Package for the Social Sciences (SPSS) using Chi-square test or Fisher Exact test. Significant value is p<0.05.

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 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Subjects aged 0-5 years old
  • Subjects with difficult vein access (e.g. edema, obesity, chemotherapy history),
  • Subjects whose parents had signed the informed consent
  • Subjects with available vein access locations at the back of either hands.

排除标准

  • Subjects who had infection signs at the designated vein access location
  • Subjects in need of emergency procedures.
  • Drop out Criteria:
  • Subjects resigned from the study
  • Subjects rejected any next attempt of intravenous cannulation
  • Subjects who received anesthetic drugs before intravenous cannulation.

结局指标

主要结局

Successful first vein cannulation attempt

时间窗: Day 1

Whether the first vein cannulation attempt successful or not will be recorded

次要结局

未报告次要终点

研究者

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

Aries Perdana

Consultant, Anesthesiologist

Indonesia University

研究点 (2)

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