Validation of a Noninvasive Automated Blood Pressure Device

Blood Pressure Clinical Trial

Official title: Validation of a Noninvasive Automated Blood Pressure Device

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Blood Pressure

• NCT number: NCT03566888
• Study type: Observational
• Source: University of Southern California
• Status: Completed
• Start date: August 1, 2017
• Completion date: October 2, 2018