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临床试验/NCT02584673
NCT02584673已完成不适用

Computer Assisted Instrument Guidance (CAIG) For Arterial Line Placement

Clear Guide Medical2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Time Needed to Correctly Insert the Arterial or Midline Catheter.

研究概览

简要总结

The objective of this research is to verify the procedural improvements enabled by use of a CAIG system to supplement existing ultrasound guided, needle-based procedures. The primary focus will be procedures performed by the Anesthesia department.

详细描述

The study will utilize two groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system. It is anticipated that 100 patients will be included in the study. After each procedure completion times, number of needle repositions, and punctures will be recorded along with an "ease of procedure" self-reported qualitative metric from the physician performing the procedure.

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
None

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

  • Undergoing vessel catheterization
  • Able to give written informed consent

排除标准

  • Unable to give informed consent
  • Prisoners, pregnant women, and children

结局指标

主要结局

Time Needed to Correctly Insert the Arterial or Midline Catheter.

时间窗: Immediately following intervention (within 2 hours)

次要结局

  • Number of Attempts(Immediately following intervention (within 2 hours))
  • Clinician Rating of the Device(Immediately following intervention (within 2 hours))
  • Number of Times Needle Needs Repositioning(Immediately following intervention (within 2 hours))

研究者

发起方
Clear Guide Medical
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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