Validation of a Noninvasive Automated Blood Pressure Device

University of Southern California

Status: Completed

Conditions: Blood Pressure

Treatments: Device: Blood pressure assessment

Study type: Observational

Funder types: Other

Identifiers

NCT03566888

HS-17-00139

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 12 to 92 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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.

Trial design

85 participants in 1 patient group

Single Group

Description:

85 eligible study participants

Treatment:

Device: Blood pressure assessment