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临床试验/NCT01877031
NCT01877031已完成不适用

Needle Guidance With Virtual Reality Augmented Ultrasound Versus Ultrasound Guidance Alone For Central Line Insertion: A Randomized Trial.

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2013年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
192
试验地点
2
主要终点
Time taken to insert needle

研究概览

简要总结

We aim to compare the use of ultrasound guidance alone versus a magnetically tracked needle to look at the time taken to place a central line, or specifically the time taken to place a needle in the internal jugular vein prior to utilizing the Seldinger technique to insert a central line.

详细描述

The purpose of this study is to examine the incremental benefit of a innovative, robust, intuitive and portable, virtual reality(VR) imaging platform capable of displaying a tracked virtual needle tip with path trajectory along with the real time ultrasound(US) image of an internal jugular vein compared to US imaging of the internal jugular vein alone to reduce the complications associated with insertion of central lines.

The studies primary outcome is the difference in time to insert a central line, from needle insertion to placement and confirmation of the wire in the internal jugular vein, compared to standard insertions using ultrasound guidance alone. Secondary outcomes will include the number of needle withdrawals, the incidence of carotid puncture and the incidence of pneumothorax. Finally, a subjective VAS rating of 1 to 10 for ease of insertion will be collected from participating anesthesiologists.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • Age 18-80
  • Require a central line inserted in the left jugular vein
  • Undergoing surgery

排除标准

  • Contraindication to left jugular vein insertion (absent vein, infection at site)
  • Permanent or temporary pacemaker
  • Emergency surgery

结局指标

主要结局

Time taken to insert needle

时间窗: within 15 minutes

Measure the time taken from needle on skin to blood in syringe

次要结局

  • Carotid Puncture(within 24 hours)
  • Attempts(15 minutes)
  • Pneumothorax(24 hours)

研究者

研究点 (2)

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