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Validation of Wrist Type Oscillometric Blood Pressure Monitorings

NCT ID: NCT04633785

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-06-30

Brief Summary

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Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.

Detailed Description

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High blood pressure (BP) is one of the major cardiovascular risk factors in adults. Home blood pressure monitoring is superior to office-based measurements for prediction of the future development of cardiovascular diseases and is recommended by major guidelines. To monitor BP at home, patients can use devices that measure BP either at the arm or at the wrist.

Among BP monitors, the wrist device is relatively easy to use, as the cuff can be used with one hand easily and correctly around the wrist than around the arm, and undressing is not necessary. Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. To make sure the performance of these devices, several guidelines have proposed protocols to validate these devices. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.

Conditions

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Blood Pressure

Keywords

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oscillometric wrist blood pressure monitor sphygmomanometer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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wrist BP

No Intervention

Intervention Type OTHER

There are no interventions in this study. The mercury sphygmomanometer and the wrist sphygmomanometer will be used in this study to collect blood pressure values from the study subjects.

Interventions

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No Intervention

There are no interventions in this study. The mercury sphygmomanometer and the wrist sphygmomanometer will be used in this study to collect blood pressure values from the study subjects.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* above 12 years old

Exclusion Criteria

* unclear Korotkoff sounds
* wrist circumference outside of the designated range (13.5-23 cm)
* arrhythmias
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hao-Min Cheng, M.D., Ph.D.

Role: STUDY_DIRECTOR

Center for Evidence-based Medicine, Taipei Veterans General Hospital, Taiwan

Central Contacts

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Hao-Min Cheng, M.D., Ph.D.

Role: CONTACT

Phone: (886)-2-28757302

Email: [email protected]

Shu-Mei Yang, Ph.D

Role: CONTACT

Phone: (886)-2-55681049

Email: [email protected]

Other Identifiers

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2020-11-001CC

Identifier Type: -

Identifier Source: org_study_id