Blood Pressure
Conditions
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.
Interventions
Validation of an automated blood pressure device
Sponsors
University of Southern California
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
12 Years to 92 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed