NCT03566888

Validation of a Noninvasive Automated Blood Pressure Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 85 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 12 Years – 92 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	Blood pressure assessment	Validation of an automated blood pressure device

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-10-02
• Completion: 2018-10-02
• First posted: 2018-06-25
• Last updated: 2018-11-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study