Clinical Trial of Wrist Ambulatory Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2018+AMD1:2020

Huawei Device Co., Ltd128 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

128

Conditions

Blood Pressure

Interventions

Wrist Ambulatory Blood Pressure MonitorDEVICE

Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer .

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects should voluntarily participate in the clinical trial and sign the informed consent form; 2. Subjects must be willing and able to follow the study procedures; 3. Subjects are over 18 years old whose wrist circumference should be within 13.0-21.0cm. Exclusion Criteria: 1. 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; 2. Subjects with sickle cell disease; 3. Subjects with prior mastectomy or arm lymph node dissection; 4. Subjects who are allergic to nylon, fluororubber or thermo-plastic polyurethane elastomer (TPU); 5. Subjects with wounds on the limb at the measurement site or inflammation of the wrist 6. Subjects who are undergoing intravenous fluid therapy, blood transfusion or other catheterization at the measurement site limb; 7. Subjects who have eaten, consumed alcohol, smoked cigarettes, or exercised vigorously 30 minutes prior to the trial; 8. Subjects who have participated in other clinical trials within 30 days that may affect this trial; 9. Subjects who, in the opinion of the investigator, should not participate in this clinical trial.

Locations (1)

Bin Peng

Chenzhou, Hunan, China

Outcomes

Primary Outcomes

Blood pressure mean deviation and standard deviation- evaluation criterion 1

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.

Time frame: 30 minutes

Blood pressure mean deviation and standard deviation- evaluation criterion 2

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.

Time frame: 30 minutes

The mean deviation and standard deviation of blood pressure measurements under ambulatory blood pressure monitoring

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.

Time frame: 30 minutes

Data from ClinicalTrials.gov

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