Clinical Trial on the Effectiveness and Safety of Blood Pressure Function System of Wrist Ambulatory Blood Pressure Monitor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Blood pressure mean deviation and standard deviation- evaluation criterion 1
研究概览
简要总结
The accuracy and safety of the Wrist Ambulatory Blood Pressure Monitor (Model: RIV-B10) were assessed according to the requirements of ISO 81060-2:2018+AMD1:2020+AMD2:2024.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Voluntarily participate in this clinical trial and sign informed consent;
- •Subjects must be willing and able to comply with the study steps;
- •Subjects aged 18 and above with wrist circumferences of 13.0-21.0 cm.
排除标准
- •Subjects whose ECG during the screening period showed severe arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, junctional tachycardia, sinus arrest, pathological sinoatrial node syndrome, pacemaker rhythm);
- •Subjects with sickle cell disease;
- •Subjects who have undergone previous mastectomy or arm lymph node resection;
- •Subjects allergic to nylon, fluor rubber, or hydrogenated nitrile rubber (HNBR);
- •Subjects with wounds on the limbs at the measurement site or inflammation in the wrist;
- •Subjects undergoing intravenous infusion, blood transfusion, or other catheter insertion at the measurement site of the limb;
- •Those who ate, drank alcohol, smoked, or exercised vigorously within 30 minutes prior to the study;
- •Subjects who have participated in other clinical investigations that may affect this trial within the past 30 days;
- •Investigator believe that subjects should not participate in this clinical trial.
结局指标
主要结局
Blood pressure mean deviation and standard deviation- evaluation criterion 1
时间窗: 30 minutes
The mean deviation and standard deviation between the blood pressure values measured by the investigational deviceand those obtained using the auscultatory method with the reference device. This calculation is performed on valid data pairsof subjects (n≥255). Evaluation criterion 1: The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.
Blood pressure mean deviation and standard deviation- evaluation criterion 2
时间窗: 30 minutes
The mean deviation and standard deviation between the blood pressure values measured by the investigational device and those obtained using the auscultatory method with the reference device. This calculation is performed on the valid data group of all subjects (m≥85). Evaluation criterion 2: The blood pressure standard deviation within the valid data group (m ≥ 85) should not exceedthe maximum allowable standard deviation corresponding to the mean deviation listed in Criterion 2 in section 5.2.4.1.2 b of ISO 81060-2:2018+AMD1:2020+AMD2:2024.
The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring
时间窗: 30 minutes
The mean deviation and standard deviation of the blood pressure within the valid data group are calculated to evaluate whether the clinical accuracy of the investigational device meets the requirements outlined in ISO 81060-2:2018+AMD1:2020+AMD2:2024 , specifically in section 5.2.4.1.2a). The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.
The mean deviation and standard deviation of blood pressure measurements under exercise stress condition
时间窗: 30 minutes
The mean deviation and standard deviation of the blood pressure within the valid data group are calculated to evaluate whether the clinical accuracy of the investigational device meets the requirements outlined in ISO 81060-2:2018+AMD1:2020+AMD2:2024, specifically in section 5.2.4.1.2a). The blood pressure mean deviation should not exceed ±5mmHg, and the standard deviation should not exceed 8mmHg.
次要结局
未报告次要终点