ivWatch Sensor: Device Validation for 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
- 99
- 试验地点
- 1
- 主要终点
- Red Notification Sensitivity to Infiltrated Tissues
研究概览
简要总结
A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.
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 by clinician
- •18 years or older
排除标准
- •Fail health screen
研究组 & 干预措施
Infiltrated Tissue
The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
干预措施: ivWatch Model 400 with SmartTouch Sensor (Device)
Infiltrated Tissue
The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
干预措施: ivWatch Model 400 with Fiber Optic Sensor (Device)
结局指标
主要结局
Red Notification Sensitivity to Infiltrated Tissues
时间窗: After each participant has been infiltrated, an expected average of 1 hour
The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.
次要结局
- Yellow Notification Sensitivity to Infiltrated Tissues(After each participant has been infiltrated, an expected average of 1 hour)
- Infiltrated Volume When Red Notification Issued(After each participant has been infiltrated, an expected average of 1 hour)
- Infiltrated Volume When Yellow Notification Issued(After each participant has been infiltrated, an expected average of 1 hour)
- Significant Skin Irritation or Disruption to Skin Integrity(After each participant has been infiltrated, an expected average of 1 hour)