Clinical Trial of Wrist Blood Pressure Monitor in Conformance With the EN ISO 81060-2:2019/A1:2020 Standard

Huawei Device

Status: Completed

Conditions: Blood Pressure

Treatments: Device: wrist blood pressure monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT05482035

CTP-YBN2021075026A2

Details and patient eligibility

About

The accuracy and safety of wrist blood pressure (model: MLY-B10) is evaluated according to the requirement of EN ISO 81060-2:2019/A1:2020.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 investigation procedures.
3. Subjects are over 18 years old whose wrist circumference should be within 13.0-20.0 cm.

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. Subject with prior allergy to nylon, fluororubber, thermoplastic polyurethane elastomer (TPU), or polyvinyl chloride (PVC) materials.
3. Subjects with prior arterial obstructive disease or arteritis.
4. Subjects who had previously undergone mastectomy.
5. Subjects with wound or wrist inflammation were measured.
6. Subjects who are receiving intravenous infusion, blood transfusion, or other catheters at the site of measurement.
7. Subjects who had eaten, drank, smoked or exercised vigorously in the 30 minutes prior to the study.
8. Subjects who have participated in other clinical trials within 30 days that may affect this trial.
9. Subjects who the investigator consider inappropriate to attend the trial.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Blood pressure measured by wrist blood pressure monitor and mercury sphygmomanometer

Experimental group

Treatment:

Device: wrist blood pressure monitor