Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Blood Pressure
- Sponsor
- Perin Health Devices
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Cuffless blood pressure measurement performance
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).
Detailed Description
The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults aged 18 years or older,
- •Willing and able to provide informed consent,
- •Able to comply with study procedure.
Exclusion Criteria
- •Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference \> 42 cm),
- •Patient with a pacemaker,
- •History of reactions to medical adhesives,
- •Inability to comply with the study procedure,
- •Non-English Speaker.
Outcomes
Primary Outcomes
Cuffless blood pressure measurement performance
Time Frame: 3 months
Calculate the mean error and standard deviation of blood pressure (BP) measurements from the PHP relative to the ambulatory blood pressure cuff and determine compliance of the PHP's performance with AAMI standards and ISO 81060-2.
Secondary Outcomes
- Demographic performance variance(3 months)