Validation of a Noninvasive Automated Blood Pressure Device

Completed

• Conditions: Blood Pressure
• Interventions: Device: Blood pressure assessment

• Registration Number: NCT03566888
• Lead Sponsor: University of Southern California

Brief Summary

The investigator's objective is to validate the novel automated blood pressure device against the requirements set forth in the AAMI_ISO 81060-2:2010 standard in voluntarily consented study participants.

Detailed Description

A new prototype blood pressure cuff has been designed for the higi SH llc health stations. This new cuff accurately captures blood pressure (BP) by emulating a fitted cuff which is used in conjunction with a mercury sphygmomanometer, the accepted gold standard for measuring BP values in most clinical facilities. The cuff is driven by a motor and gearhead to automatically "wrap" the cuff around a user's arm when they initiate a BP test. A BP measurement is then taken by an Original Equipment Manufacturer (OEM) BP module using an algorithm developed for use with a fitted cuff; the same module one would expect to find in a clinic or doctor's office. For the device to pass the AAMI_ISO 81060-2:2010 standard statistical requirements and thus, be considered a valid device for measuring BP it will need to meet the standards criteria 1 and 2.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-06-12
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-06-25
• Primary Completion: 2018-10-02
• Study Completion: 2018-10-02
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• between the ages of 12 to 92 years of age.
• generally healthy but can be on medication for blood pressure regulation.

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Exclusion Criteria

• heart disease is present such as, coronary artery disease, cardiomegaly, irregular heart rhythm, atrial fibrillation, heart valve disease, congenital heart disease, cardiomyopathy, pericardial effusion, Marfan syndrome, and heart murmurs.
• using a pacemaker to maintain a suitable heart rate.
• missing their natural left arm.
• exhibit a musculoskeletal disorder that may prevent them from sitting upright for a period of time (~40min) or prevent a BP reading taken from the left arm.
• Special populations, for example pregnant women and patients with known arrhythmias.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single Group	Blood pressure assessment	85 eligible study participants

Primary Outcome Measures

Name	Time	Method
Systolic and Diastolic blood pressure (criteria 1 and 2)	60 minutes	Mean value of the differences of the paired (i.e., device under test - reference method) determinations for all study participants shall be within or equal to ± 5 mmHg with a standard deviation no greater than 8 mmHg (criterion 1). Standard deviation of the averaged paired determinations per participant shall meet the criterion 2 listed in the standard.

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States