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

Not Applicable

Completed

• Conditions: Blood Pressure
• Interventions: Device: wrist blood pressure monitor

• Registration Number: NCT05482035
• Lead Sponsor: Huawei Device Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-16
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-07
• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Last Update Submitted: 2022-07-28
• Study First Posted: 2022-08-01
• Last Update Posted: 2022-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood pressure measured by wrist blood pressure monitor and mercury sphygmomanometer	wrist blood pressure monitor	-

Primary Outcome Measures

Name	Time	Method
mean difference of systolic blood pressure	30 minutes	mean difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer
standard deviation of the difference of diastolic blood pressure	30 minutes	standard deviation of the difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer
mean difference of diastolic blood pressure	30 minutes	mean difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer
standard deviation of the difference of systolic blood pressure	30 minutes	standard deviation of the difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer

Trial Locations

Locations (1)

Shenzhen No.2 People's Hospital; 🇨🇳 Shenzhen, Guangdong, China