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

Blood Pressure Clinical Trial

Official title:

Clinical Trial on the Effectiveness of Blood Pressure Function of Wrist Blood Pressure Monitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05482035
• Other study ID #: CTP-YBN2021075026A2
• Status: Completed
• Phase: N/A
• Start date: February 16, 2022
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2022
• Source: Huawei Device Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• wrist blood pressure monitor
Comparing blood pressure measured by wrist blood pressure monitor with mercury sphygmomanometer .

Locations

Country	Name	City	State
China	Shenzhen No.2 People's Hospital	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Huawei Device Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean difference of systolic blood pressure	mean difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer	30 minutes
Primary	mean difference of diastolic blood pressure	mean difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer	30 minutes
Primary	standard deviation of the difference of systolic blood pressure	standard deviation of the difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer	30 minutes
Primary	standard deviation of the difference of diastolic blood pressure	standard deviation of the difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer	30 minutes