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
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
- 否
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
研究点 (1)
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