A Clinical Evaluation of Omron Digital Blood Pressure Monitor

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

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: OMRON blood pressure monitor HEM-9210T

• Study Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• Japan
  • Muko, Japan, 6170002
    • OMRON HEALTHCARE CO., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Resident of a community

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Omron Healthcare Co., Ltd.
• Collaborators: Biwako Chuo Hospital Japan; Shared Care Research and Education Consulting,. Inc. US

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2015
• Primary Completion (Actual): February 18, 2016
• Study Completion (Actual): March 31, 2016

Study Registration Dates

• First Submitted: April 17, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 24, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HDV-TCD-150311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No plan to share the data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes