M- HEALTHCARE Confirmatory Clinical Trials Used for Measurement of the ABP for the Accuracy and Safety Assessment of the Module Measuring Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- mean difference of systolic blood pressure
研究概览
简要总结
The accuracy and safety of blood pressure module of new mobile device (M- HEALTHCARE device) is evaluated according to Korean FDA guidelines in 100 healthy volunteers.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants whose systolic blood pressure <=110 should be at least 10% of whole cohort
- •Participants whose systolic blood pressure >=160 should be at least 10% of whole cohort
- •Participants whose diastolic blood pressure >=100 should be at least 10% of whole cohort
- •Participants whose diastolic blood pressure <=70 should be at least 10% of whole cohort
- •Participants whose arm circumference are between 20cm and 30cm should be 25 - 50% of whole cohort
- •Participants whose arm circumference are between 30cm and 40cm should be 50 - 75% of whole cohort
排除标准
- •heart disease with abnormal rhythm
- •peripheral vascular anomaly or disease
- •inadequate to be applied blood pressure cuff (e.g. trauma on arm)
- •pregnant or lactating women
研究组 & 干预措施
EXPERIMENTAL
Blood pressure check using mobile device and control device
干预措施: blood pressure check (Device)
结局指标
主要结局
mean difference of systolic blood pressure
时间窗: 1 day at visit 2
mean difference of blood pressure between new and control device
mean difference of diastolic blood pressure
时间窗: 1 day at visit 2
mean difference of diastolic blood pressure between new and control device
standard deviation of the difference of systolic blood pressure
时间窗: 1 day at visit 2
standard deviation of the difference of systolic blood pressure between new and control device
standard deviation of the difference of diastolic blood pressure
时间窗: 1 day at visit 2
standard deviation of the difference of diastolic blood pressure between new and control device
次要结局
未报告次要终点