Validation of a Noninvasive Automated Blood Pressure Device

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Blood pressure assessment

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.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 92 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Individuals between the ages of 12-92 years, generally healthy, and have not been diagnosed with heart disease.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single Group; 85 eligible study participants	Device: Blood pressure assessment; Validation of an automated blood pressure device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 minutes

Collaborators and Investigators

• Sponsor: University of Southern California
• Investigators: Principal Investigator: Todd Schroeder, PhD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): October 2, 2018
• Study Completion (Actual): October 2, 2018

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: HS-17-00139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No