A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
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 attempt success
研究概览
简要总结
Two-dimensional ultrasound guided approach does not guarantee first attempt success on internal jugular vein cannulation. New attachable device recently was developed for accurate needle insertion when ultrasound is used. Our randomized parallel simulation study will examine whether this device will improve the first attempt success rate when ultrasound guided internal jugular vein catheterization of simulated internal jugular vein.
详细描述
This was a prospective, randomized, parallel trial using phantom simulating internal jugular vein.
After informed consent all subjects will be randomized to insert needle for internal jugular vein cannulation of phantom using ultrasound approach with or without this device. Video camera will record all procedure process and ultrasound image in real time. Researchers blinded to the study aim measured outcome variables based on recorded images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded to study arm, Outcome assessor measured outcome variables based on recorded images.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults over 20
- •Resident in clinical hospital
- •Ultrasound-guided internal jugular vein insertion without supervisor experience less than 10
排除标准
- •If they have physical problem that is difficult to perform
- •If they do not want to participate in this study
- •If they can not understand the contents reading the informed consent
- •If they have more than 10 ultrasound guided internal jugular vein insertion without supervisor
研究组 & 干预措施
Conventional group
participants who are tested performance for ultrasound guided cannulation using conventional method
干预措施: UGIJVC without needle guide device (Device)
New device group
participants who are tested performance for ultrasound guided cannulation using device
干预措施: UGIJVC with needle guide device (Device)
结局指标
主要结局
First attempt success
时间窗: Within 2 minutes or after start to insertion attempt
The first attempt success was defined as a successful attempt to perform a vein puncture in one attempt. The number of attempts was counted each time a subject inserted a guide needle into the phantom surface, followed by withdrawal, redirect, or reinsertion.
次要结局
- Posterior wall puncture of the internal jugular procedure, comfort level with procedure(Within 2 minutes or after start to insertion attempt)
- Carotid artery puncture(Within 2 minutes or after start to insertion attempt)
- Time to cannulation(Within 2 minutes or after start to insertion attempt)
- Comfort level(Within 2 minutes or after start to insertion attempt)