Validation of Wrist Type Oscillometric Blood Pressure Monitorings

NCT04633785 | Unknown

• 1 other identifier: 2020-11-001CC
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Pressure

Keywords

oscillometric; wrist blood pressure monitor; sphygmomanometer

Outcome Measures

Primary Outcomes (1)

• Validation

  The present study will be aimed to evaluate the accuracy of the wrist type oscillometric blood pressure monitorings.

  7 months

Study Arms (1)

wrist BP

Other: No Intervention

Interventions

No Intervention 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.

wrist BP

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from outpatient clinics at Taipei Veterans General Hospital from 2020 to 2021. A total of 100 subjects will be enrolled in the study, and informed consent forms will be obtained from before measurements. In accordance with the ANSI/AAMI/ISO, subjects will be screened to ensure that sex, age, wrist circumference, and BP readings fulfilled the participation requirements described in those protocols. If subjects aged less than 12 years old, having wrist circumference outside of the designated range (13.5-23 cm), having arrhythmias, who moved their arms or bodies during the BP measurements, and have unclear Korotkoff sounds will be excluded from this study.

You may qualify if:

• above 12 years old

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Officials

• Hao-Min Cheng, M.D., Ph.D.

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

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

(886)-2-28757302; hmcheng@vghtpe.gov.tw

Shu-Mei Yang, Ph.D

CONTACT

(886)-2-55681049; stellarsirius@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 18, 2020
• Study Start: December 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share