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Validation of Wrist Type Oscillometric Blood Pressure Monitorings

Validation of Wrist Type Oscillometric Blood Pressure Monitorings

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04633785
Enrollment
100
Registered
2020-11-18
Start date
2020-12-01
Completion date
2021-06-30
Last updated
2020-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

oscillometric, wrist blood pressure monitor, sphygmomanometer

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.

Interventions

OTHERNo 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.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* above 12 years old

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Validation7 monthsThe present study will be aimed to evaluate the accuracy of the wrist type oscillometric blood pressure monitorings.

Contacts

Primary ContactHao-Min Cheng, M.D., Ph.D.
hmcheng@vghtpe.gov.tw(886)-2-28757302
Backup ContactShu-Mei Yang, Ph.D
stellarsirius@gmail.com(886)-2-55681049

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026