跳至主要内容
临床试验/NCT03390543
NCT03390543撤回不适用

The Effect of Simple Needle Guide Device for Ultrasound-guided Internal Jugular Vein Catheterization in Cardiac Surgical Patients: a Randomized-controlled Trial

Yonsei University2 个研究点 分布在 1 个国家开始时间: 2018年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
First access success rate

研究概览

简要总结

The purpose of this study is to evaluate the effect of simple needle guide device for ultrasound-guided internal jugular vein catheterization in cardiac surgical patients

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

participants, investicator, outcome assessors will be blinded for group allocation.

入排标准

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

入选标准

  • adult ( ≧19 years old)
  • patients undergoing elective cardiac surgery

排除标准

  • emergency surgery
  • patients under cervical immobilization
  • anatomical abnormality
  • infection or hematoma at puncture site
  • patients who did not need internal jugular vein catheterization

研究组 & 干预措施

Device group (Group D)

Experimental

Arm Description: Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound and simple needle guide device.

干预措施: Sono with Device (Device)

sono only group (Group S)

Placebo Comparator

Patients in this group are assigned to receive internal jugular vein catheterization guided by ultrasound without simple needle guide device.

干预措施: sono only (Device)

结局指标

主要结局

First access success rate

时间窗: up to 5 minutes after insertion of puncture needle

First access success rate was defined as the number of sono-guided catheterization obtained within first attempt.

次要结局

  • complication rate(24 hours after surgery)
  • ease of procedure(10 minutes after the beginning of the procedure)
  • The number of attempts(10 minutes after the beginning of the procedure)
  • insertion time(10 minutes after the beginning of the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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