Validation of a Noninvasive Automated Blood Pressure Device
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- University of Southern California
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Systolic and Diastolic blood pressure (criteria 1 and 2)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Todd Schroeder
Assistant Professor
University of Southern California
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Systolic and Diastolic blood pressure (criteria 1 and 2)
Time Frame: 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.