Validation of a Noninvasive Automated Blood Pressure Device

NCT03566888 | Completed FDA Device

• 1 other identifier: HS-17-00139
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single Group

85 eligible study participants

Device: Blood pressure assessment

Interventions

Blood pressure assessment DEVICE

Validation of an automated blood pressure device

Single Group

Eligibility Criteria

• Age: 12 Years - 92 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• between the ages of 12 to 92 years of age.
• generally healthy but can be on medication for blood pressure regulation.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Study Officials

• Todd Schroeder, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: June 25, 2018
• Study Start: August 1, 2017
• Primary Completion: October 2, 2018
• Study Completion: October 2, 2018
• Last Updated: November 8, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)