跳至主要内容
临床试验/NCT03595137
NCT03595137Unknown不适用

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

Yonsei University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年7月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
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 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)

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 surgery

排除标准

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

研究组 & 干预措施

sono with simple needle guide device group (Group D)

Experimental

sono with simple needle guide device Simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.

干预措施: Sono with Device (Device)

sono only group (Group S)

Placebo Comparator

sono only group After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.

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

  • insertion time(10 minutes after the beginning of the procedure)
  • ease of procedure(10 minutes after the beginning of the procedure)
  • the number of separate skin puncture(10 minutes after the beginning of the procedure)
  • complication rate(24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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