Accuracy Study of a Non-Invasive Forearm Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading
研究概览
简要总结
The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.
详细描述
Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 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 provide written informed consent
- •Any volunteer subjects ≥ 18 years of age
- •Subject must have the presence of normal sinus rhythm on ECG
- •Subject will return for follow-up visit from 5 days to 8 days after study procedure
排除标准
- •Any subject who is unable to provide written informed consent
- •Any subject with the presence of peripheral vascular disease in either arm
- •Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled.
- •Any subject who cannot tolerate 21 repeated BP measurements
- •Any subjects with clotting or bleeding disorders
- •Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin)
- •Any subject who is unable to have arterial line placed in the radial artery
- •Any subject that cannot tolerate 4 fast flushes for the frequency response
- •Any female subjects pregnant or lactating
- •Any subject that has previously participated in this study
- •Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit
结局指标
主要结局
Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading
时间窗: Approximately 2 hours
NIBP Forearm cuff systolic and diastolic values using Classic algorithm difference compared to invasive radial blood pressure readings (both readings obtained simultaneously).
Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading
时间窗: Approximately 2 hours
NIBP Forearm cuff systolic and diastolic values using SuperStat algorithm compared to invasive radial blood pressure systolic and diastolic values (both obtained simultaneously).
次要结局
未报告次要终点