Non-invasive, Non-Oscillometric Blood Pressure Band
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Blood Pressure Monitoring
研究概览
简要总结
A wristband device intended for use as a standalone device, designed for the measurement of intermittent blood pressure, as well as other physiological signals. The device is intended to be worn in day to day life by individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance.
详细描述
The device is intended to be worn on the wrist for intermittent measurements of vital signs such as HR, blood pressure, Skin temperature and activity.
The use does not require any special action from the user apart form wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The waistband is watertight and can be worn as any type of bracelet all the time of most of the time.
The study will focus on patients in intensive care or any other cardiology unit who are under continuous oversight of existing Invasive (A-line Gold Standard monitors
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Signed written Institution approved Informed Consent Form (ICF)
- •Male and Females over the age of 18 years
- •Patients in intensive care or cardiology units who are under continuous oversight of existing Invasive (A-Line) Gold Standard monitors.
- •Only subjects who are fitted with an invasive Arterial Line (A LINE)
- •To the extent possible, individuals who have not been using medication 5 (five) hours prior to the test shall be classified as non-medicated subjects.
排除标准
- •Subject who are unable to provide consent
- •Where it would be impractical or inconvenient or otherwise unfeasible to place to place a wristband and generate a signal.
- •Subjects who are not fitted with, or not planned to be fitted with an A-Line during their stay in the hospital.
结局指标
主要结局
Blood Pressure Monitoring
时间窗: 30-60 seconds of a clean signal from the A-line monitor
Wearing of a non invasive wristband to measure Blood Pressure
次要结局
未报告次要终点