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临床试验/NCT01476293
NCT01476293已完成不适用

Non-invasive Optical Medical Device for Monitoring and Detecting Peripheral Intravenous Infusion Sites for Infiltration and Extravasation in Subjects Receiving Continuous Fluids

ivWatch, LLC1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
ivWatch, LLC
入组人数
139
试验地点
1
主要终点
Test performance of optical device for monitoring intravenous infusion site for infiltration.

研究概览

简要总结

The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an indication that the PIV is leaking fluids outside of the vascular system. The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
— 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • signed consent
  • patient age under 12
  • PIV with continuous fluids

排除标准

  • no consent
  • patient age over 12
  • PIV fluids not continuous

结局指标

主要结局

Test performance of optical device for monitoring intravenous infusion site for infiltration.

时间窗: 6 months

次要结局

未报告次要终点

研究者

发起方
ivWatch, LLC
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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