SNIPE:SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Data Collection for Engineering Development
研究概览
简要总结
The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
- •Ability of a minor subject ages 7 to 18 to provide written assent
- •Ability to have multiple noninvasive blood pressures taken at one sitting
- •Ability to apply three lead ECG, if needed for investigation
- •Ability to detect the natural presence of an irregular pulse, for irregular pulse studies
排除标准
- •Any subject who cannot tolerate multiple blood pressure measurements
- •Any subject who cannot undergo 3-lead ECG, if needed
- •Any subject deemed unstable by the principal investigator
- •Any subject for whom precautions are necessary because of communicable disease
- •Any subject that has a known disease or condition compromises musculoskeletal integrity
- •Any subject that has a known disease or condition that contraindicates use of an NIBP cuff and ECG patches on the skin.
研究组 & 干预措施
Subjects requiring blood pressure monitoring
Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring
干预措施: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor (Device)
结局指标
主要结局
Data Collection for Engineering Development
时间窗: After each iteration of software development
This was a data collection for engineering development to demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications. Engineers reviewed data produced by each blood pressure determination to work on new software algorithm in development. This was not conducted as program was terminated prematurely. Software iterations are not pre-defined.
次要结局
未报告次要终点