Protocol for Evaluation of EarlySense: A Contact-less Device for Monitoring Changes in Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices
研究概览
简要总结
The study objective is to assess the accuracy of Earlysense contactless monitoring to detect changes in blood pressure vs. Gold reference method / devices including ambulatory blood pressure monitoring device (ABPM) or invasive blood pressure monitoring for patients who have arterial line as part of their standard clinical care.
详细描述
The study objective is to collect data to assess the accuracy and reliability of Earlysense contactless monitoring for blood pressure monitoring vs. gold reference methods such as ABPM (Ambulatory blood pressure measurement) for patients hospitalized in Internal Medicine department and vs. Arterial Line measurements for patients hospitalized in ICU. In addition the collected data will be used to further enhance and improve the existing algorithms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and up
- •Patients hospitalized that require stabilization of his/ her blood Pressure
- •Is willing to sign the consent form.
- •Group II: Patients hospitalized in Intensive Care
- •Age 18 years and up in intensive care with arterial line that allows invasive Blood Pressure measurements
- •Patient or next of kin or legal guardian are willing to sign consent form
排除标准
- •Age < 18 years
- •Does not sleep on a mattress that allows placing EarlySense sensor under it
- •Patient or next of kin or legal guardian is not willing to sign consent form
结局指标
主要结局
Evaluate accuracy: Blood pressure measured by the EarlySense system in comparison with Gold Standard Devices
时间窗: 3 months
Determine the accuracy of the EarlySense system to measure blood pressure in a contactless way: we would like to see what were the BP measurements in the Gold Standard Devices, compares to what the EarlySense System was measuring at the same time
次要结局
未报告次要终点