Validation of Wrist Type Oscillometric Blood Pressure Monitorings

• Conditions: Blood Pressure
• Interventions: Other: No Intervention

• Registration Number: NCT04633785
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-11
• Last Update Submitted: 2020-11-11
• Study First Posted: 2020-11-18
• Last Update Posted: 2020-11-18
• Study Start: 2020-12-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• above 12 years old

Exclusion Criteria

• unclear Korotkoff sounds
• wrist circumference outside of the designated range (13.5-23 cm)
• arrhythmias

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
wrist BP	No Intervention	-

Primary Outcome Measures

Name	Time	Method
Validation	7 months	The present study will be aimed to evaluate the accuracy of the wrist type oscillometric blood pressure monitorings.