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Completed

NCT Number: NCT05482035

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

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.

Completed

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen No.2 People's Hospital

Shenzhen, Guangdong, 518035, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects should voluntarily participate in the clinical trial and sign the informed consent form.
  • Subjects must be willing and able to follow the investigation procedures.
  • Subjects are over 18 years old whose wrist circumference should be within 13.0-20.0 cm.

Exclusion criteria

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

Treatment and study plan

wrist blood pressure monitor

Device

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

Primary outcomes

  1. mean difference of systolic blood pressure

    Time frame: 30 minutes

    mean difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer

  2. mean difference of diastolic blood pressure

    Time frame: 30 minutes

    mean difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer

  3. standard deviation of the difference of systolic blood pressure

    Time frame: 30 minutes

    standard deviation of the difference of systolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer

  4. standard deviation of the difference of diastolic blood pressure

    Time frame: 30 minutes

    standard deviation of the difference of diastolic blood pressure between wrist blood pressure monitor and mercury sphygmomanometer

Sponsors and collaborators

Lead sponsor

Huawei Device Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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