ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ivWatch, LLC
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Normal Tissue Red Notification Rate
研究概览
简要总结
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Informed consent
- •Pass health screen
- •18 years or older
排除标准
- •Fail health screen
研究组 & 干预措施
Non-Infiltrated Tissue
The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
干预措施: ivWatch Model 400 (Device)
结局指标
主要结局
Normal Tissue Red Notification Rate
时间窗: 24 hours
The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using the Clopper-Pearson method.
次要结局
- Normal Tissue Yellow Notification Rate(24 hours)
- Significant Skin Irritation or Disruption to Skin Integrity(24 hours)
研究者
Garret Bonnema
Chief Science Officer
ivWatch, LLC