An observational study in Blood Pressure, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 12 Years to 92 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-08.
Sponsored by University of Southern California · Observational
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.
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.
University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals between the ages of 12-92 years, generally healthy, and have not been diagnosed with heart disease.
Exclusion Criteria:
85 eligible study participants
Device: Blood pressure assessment
Validation of an automated blood pressure device
Systolic and Diastolic blood pressure (criteria 1 and 2)
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.
Time frame: 60 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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University of Southern California