Prospective Open Study for the Development of CS6BP Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Collection of data from CardicacSense1BP measurements for algorithm development
研究概览
简要总结
The primary objective of this research is to collect data to develop an algorithm for continuous, non-inflating measurement of absolute, long-term Blood Pressure using the CS6BP device and to evaluate the safety of the CS6BP.
详细描述
The study will take place in the ICU (Intensive Care Unit) on non-anesthetized subjects with an arterial line inserted into the radial artery. The CS6BP non-invasive continuous recording will be collected parallel to an invasive arterial line recording. ECG data that was recorded in the ICU will be collected as well.
The study will include up to 80 subjects.
The subject may be measured by the CS6BP device more than once to check reproducibility. The first measurement may take up to 24h; Subsequent measurements may take up to 5h. All the data analysis will be done offline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 否
入选标准
- •Age of eighteen (18) year and above
- •Ability and willingness to sign an informed consent form
- •Monitored by radial arterial line
排除标准
- •Subjects with hemodynamic support
- •Subjects receiving more than 2-3 l of fluid per 24h
- •Subjects with septic shock
- •Subjects with distal edema
- •Subjects with arms trauma, where the watch is not wearable
- •Subjects where the radial artery could not be palpate
- •Subjects with life expectancy of less than 24h.
- •Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study
- •Any concomitant condition which, in the opinion of the investigator, would not allow safe participation in the study (e.g. drug addiction, alcohol abuse, emotional/psychological diagnosis)
研究组 & 干预措施
Blood pressure monitor
The CS6BP device will be placed on non-anesthetized subjects in the ICU (Intensive Care Unit) with arterial line placement in the radial artery. The first measurement will be for up to 24h; subsequent measures will be up to 5h.
干预措施: Arterial LIne (Device)
结局指标
主要结局
Collection of data from CardicacSense1BP measurements for algorithm development
时间窗: measurement time (up to 24 hours)
CardicacSense1BP data will be collected in parallel with blood pressure data from ICU a- line .
Safety of CardiacSense 1BP: Incidence and severity of device related Adverse Events
时间窗: measurement time (up to 24 hours)
Incidence and severity of device related Adverse Events
次要结局
未报告次要终点