Validation of a Noninvasive Automated Blood Pressure Device

Blood Pressure Clinical Trial

Official title:

Validation of a Noninvasive Automated Blood Pressure Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03566888
• Other study ID #: HS-17-00139
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: October 2, 2018

Study information

• Verified date: November 2018
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: October 2, 2018
• Est. primary completion date: October 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 92 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Device:
• Blood pressure assessment
Validation of an automated blood pressure device

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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