跳至主要内容
临床试验/NCT01126710
NCT01126710已完成不适用

Optical Detection of Intravenous Infiltration

CW Optics, Inc.1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2010年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
263
试验地点
1
主要终点
Test performance of novel optical device for monitoring intravenous infusion site for infiltration.

研究概览

简要总结

The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed for monitoring the intravenous infusion site for infiltration. The hypothesis is that the changes in optical signals measured near the infusion site using the optical device can be used to monitor intravenous infusion for infiltration.

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
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects will have peripheral IV catheter with active infusions that are anticipated to be in place and functioning for 48-72 hours. The IVs and accompanying infusions are solely a part of the subject's medical care and are not started or terminated for the purposes of this Study. The rationale for choosing this time frame is that the rate of infiltration is likely to be increased the longer the IV infusion is taking place.
  • Subjects are admitted to one of the institution's intensive care or intermediate care units, including Adult Emergency Department, Pediatric Emergency Department, Adult Medical Intensive Care Unit, Pediatric Intensive Care Unit, Neonatal Intensive Care Unity, Surgical-Trauma Intensive Care Unit, Cardiothoracic Surgery Intensive Care Unit, Neuroscience Intensive Care Unit, Burn Intensive Care Unit, Transplant Intensive Care Unit, Coronary Care Intensive Care Unit, Post-Anesthesia Recovery Unit, Pediatric Intermediate Care Unity, Surgical Intermediate Care Unit, and Medical Intermediate Care Unit.

排除标准

  • Inability to consent
  • Lack of a peripheral IV

结局指标

主要结局

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

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Leonard Winchester, Ph.D.

Chief Scientific Officer, CW Optics, Inc.

CW Optics, Inc.

研究点 (1)

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