A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device
2017年8月14日 更新者：Yonsei University
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
88
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Seoul、大韩民国、03722
- Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adults over 20
- Resident in clinical hospital
- Ultrasound-guided internal jugular vein insertion without supervisor experience less than 10
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：New device group
participants who are tested performance for ultrasound guided cannulation using device
|
Study subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces.
On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field.
The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom.
After that, all subjects were instructed to perform hands on practice for 30 minutes.
In case group, the instructor trained subjects using device.
On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device.
|
|
有源比较器：Conventional group
participants who are tested performance for ultrasound guided cannulation using conventional method
|
participants who are tested performance for ultrasound guided cannulation using conventional method.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
First attempt success
大体时间：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.
|
Within 2 minutes or after start to insertion attempt
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Posterior wall puncture of the internal jugular procedure, comfort level with procedure
大体时间：Within 2 minutes or after start to insertion attempt
|
It was defined when the needle tip on the recorded ultrasound screen was confirmed to pass through the posterior wall measurement unit : Yes or no (categorical variable)
|
Within 2 minutes or after start to insertion attempt
|
|
Carotid artery puncture
大体时间：Within 2 minutes or after start to insertion attempt
|
It was defined as the needle tip passing through the carotid lumen or the subject regurgitating artery water during cannulation attempt. measurement unit : Yes or no (categorical variable) |
Within 2 minutes or after start to insertion attempt
|
|
Time to cannulation
大体时间：Within 2 minutes or after start to insertion attempt
|
It was defined as the time from time out for procedure start to end point measurement unit : second
|
Within 2 minutes or after start to insertion attempt
|
|
Comfort level
大体时间：Within 2 minutes or after start to insertion attempt
|
It was defined subjective opinion about difficulty during procedure for each subject measurement unit : 100-mm visual analogue scale with 0 being the least of the difficulties and 10 being the highest.
|
Within 2 minutes or after start to insertion attempt
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年3月11日
初级完成 (实际的)
2017年6月24日
研究完成 (实际的)
2017年6月24日
研究注册日期
首次提交
2017年7月28日
首先提交符合 QC 标准的
2017年8月14日
首次发布 (实际的)
2017年8月17日
研究记录更新
最后更新发布 (实际的)
2017年8月17日
上次提交的符合 QC 标准的更新
2017年8月14日
最后验证
2017年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 1-2016-0081
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.