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NCT03130686 Clinical Trial

A Clinical Evaluation of Omron Digital Blood Pressure Monitor

Blood Pressure Clinical Trial

Official title:
A Clinical Evaluation of OMRON Digital Blood Pressure Monitor, HEM-9210T, Blood Pressure Measurement Accuracy Based on Auscultation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03130686
Other study ID # HDV-TCD-150311
Secondary ID
Status Completed
Phase N/A
First received April 17, 2017
Last updated April 24, 2017
Start date December 21, 2015
Est. completion date March 31, 2016

Study information
Verified date April 2017
Source Omron Healthcare Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.

Recruitment information / eligibility
Status Completed
Enrollment 92
Est. completion date March 31, 2016
Est. primary completion date February 18, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Upper arm circumference: 17-50cm

Exclusion Criteria:

- Patients who has arrhythmia.

- When body motion is observed during measurement.

- Korotkoff sound is poor quality.

- Patient's arm circumference is outside cuff range.

- Patient's auscultatory systolic blood pressure readings differ by more than 12mmHg. and patient's diastolic blood pressure readings differ by more than 8mmHg.

- Patients stated they did not wish to continue with the study and it is stopped before completion.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• OMRON blood pressure monitor HEM-9210T
To measure systolic blood pressure, diastolic blood pressure and pulse rate in patients.

Locations
Country Name City State
Japan OMRON HEALTHCARE CO., Ltd. Muko

Sponsors (3)
Lead Sponsor Collaborator
Omron Healthcare Co., Ltd. Biwako Chuo Hospital Japan, Shared Care Research and Education Consulting,. Inc. US

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Verify the accuracy of measure functions of device The aims of this study was to assess the accuracy of the Omron blood pressure monitor according to the ANSI/AAMI/ISO81060-2:2013. And it is analyzed and evaluated at least 85 patients based on the AAMI/ANSI/ISO81060-2:2013. 30 days
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