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
- 128
- 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 Recorder (Model: LCA-B10) were assessed according to the requirements of EN ISO 81060-2:2018 + AMD1:2020.
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
- •Subjects should voluntarily participate in the clinical trial and sign the informed consent form;
- •Subjects must be willing and able to follow the study procedures;
- •Subjects are over 18 years old whose wrist circumference should be within 13.0-21.0cm.
排除标准
- •Subjects with serious arrhythmias (atrial fibrillation, atrial flutter, ventricular flutter, ventricular fibrillation, ventricular tachycardia, borderline tachycardia, sinus arrest, pathological sinus syndrome, pacemaker rhythm) showed by electrocardiogram during screening period;
- •Subjects with sickle cell disease;
- •Subjects with prior mastectomy or arm lymph node dissection;
- •Subjects who are allergic to nylon, fluororubber or thermo-plastic polyurethane elastomer (TPU);
- •Subjects with wounds on the limb at the measurement site or inflammation of the wrist
- •Subjects who are undergoing intravenous fluid therapy, blood transfusion or other catheterization at the measurement site limb;
- •Subjects who have eaten, consumed alcohol, smoked cigarettes, or exercised vigorously 30 minutes prior to the trial;
- •Subjects who have participated in other clinical trials within 30 days that may affect this trial;
- •Subjects who, in the opinion of the investigator, 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 device and 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 exceed the 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.
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, 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