A Clinical Evaluation of Omron Digital Blood Pressure Monitor
Completed
- Conditions
- Blood Pressure
- Registration Number
- NCT03130686
- Lead Sponsor
- Omron Healthcare Co., Ltd.
- Brief Summary
The purpose of this study is to measure the blood pressure level of the patients, using a cuff ranged 17 - 50 cm.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Verify the accuracy of measure functions of device 30 days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
OMRON HEALTHCARE CO., Ltd.
🇯🇵Muko, Japan