Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2018+AMD1:2020
- Conditions
- Blood Pressure
- Interventions
- Device: Wrist Ambulatory Blood Pressure Monitor
- Registration Number
- NCT06573216
- Lead Sponsor
- Huawei Device Co., Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Blood pressure measured by wrist ambulatory blood pressure monitor and mercury sphygmomanometer Wrist Ambulatory Blood Pressure Monitor -
- Primary Outcome Measures
Name Time Method Blood pressure mean deviation and standard deviation- evaluation criterion 1 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 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 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bin Peng
🇨🇳Chenzhou, Hunan, China