Feasibility and Accuracy of Wireless Transmission of Invasive Blood Pressure Signal From Patient to Patient's Bedside Monitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Difference between wired and wireless invasive arterial blood pressure
研究概览
简要总结
The purpose of this study is to determine whether wireless transmission of invasive arterial blood pressure signal (by HMW 10 Wireless System) from patient to patient's bedside monitor is feasible, safe and as accurate as conventional cable connection.
详细描述
The technology for invasive arterial blood pressure measurement in emergency room, operating theater, recovery room and intensive care unit is well established and uses pressure sensor connected via cable to patient's bedside monitor. The wireless sensors result in reduction of wires attached to the patient and may enhance nursing, treatment and transportation of patients in aforementioned setting.
The HMW 10 Wireless System was developed and incorporates wireless transmission of patient's signal. The purpose of the study was to measure the quality of data transmitted through the HMW 10 Wireless System, and to demonstrate that the quality of the data meets the requirements of European Directive 93/42/EEC (Medical Device Directive - MDD) and EN/IEC 60601-1 and EN/IEC 60601-2-34.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients requiring invasive blood pressure monitoring
排除标准
- •frequent blood sampling through arterial cannula (more than 3 times a day)
结局指标
主要结局
Difference between wired and wireless invasive arterial blood pressure
时间窗: 24 hours of monitoring
次要结局
未报告次要终点