Anonymized Data Collection From the CS6BP and Other Modalities for the Purpose of Developing Continuous, Absolute, Non-Inflating Measurement of Blood Pressure
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Performance of CS6BP
研究概览
简要总结
This study is performed on hospitalized subjects in the Internal Medicine Division. The study is intended for data collection. The data will be obtained from commercially available blood pressure monitors and simultaneously from the CS6BP watch.
详细描述
This is a prospective open-label study. Hospitalized subjects from Internal Medicine Division will be measured simultaneously with a commercially available blood pressure monitor and CS6BP watch. Subjects may be measured at the clinic or home up to one month following their discharge from the hospital.
Screening:
PI or delegated physician will confirm the eligibility of subjects. Eligible subjects will sign an informed consent form before any study procedure initiation.
Recording session during hospitalization:
Each subject will undergo up to 15 blood pressure measurement sessions during the hospitalization period. The subject will be connected to the CS6BP device and a cuff simultaneously during the session. There will be at least 30 minutes intervals between the end of the session to the beginning of the next session.
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
盲法说明
open label study
入排标准
- 年龄范围
- 18 Years 至 120 Years（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
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)
结局指标
主要结局
Performance of CS6BP
时间窗: up to 1 month
Assessment of the performance sensitivity of CS6BP in measuring blood pressure
Safety Any adverse event observed during the study will be recorded during the study.
时间窗: through study completion, an average of 18 months
Assessment of the safety of using CS6BP for blood pressure measurement
次要结局
未报告次要终点