NCT03130686已完成不适用
A Clinical Evaluation of OMRON Digital Blood Pressure Monitor, HEM-9210T, Blood Pressure Measurement Accuracy Based on Auscultation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Verify the accuracy of measure functions of device
研究概览
简要总结
The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Upper arm circumference: 17-50cm
排除标准
- •Patients who has arrhythmia.
- •When body motion is observed during measurement.
- •Korotkoff sound is poor quality.
- •Patient's arm circumference is outside cuff range.
- •Patient's auscultatory systolic blood pressure readings differ by more than 12mmHg. and patient's diastolic blood pressure readings differ by more than 8mmHg.
- •Patients stated they did not wish to continue with the study and it is stopped before completion.
结局指标
主要结局
Verify the accuracy of measure functions of device
时间窗: 30 days
The aims of this study was to assess the accuracy of the Omron blood pressure monitor according to the ANSI/AAMI/ISO81060-2:2013. And it is analyzed and evaluated at least 85 patients based on the AAMI/ANSI/ISO81060-2:2013.
次要结局
未报告次要终点
研究者
研究点 (1)
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