Hypertension, Healthy
Conditions
Keywords
Blood Pressure, Cuff less, Wearable, BP
Brief summary
(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.
Detailed description
(1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.
Interventions
DEVICEViTrack
ViTrack is a continuous non-invasive wearable blood pressure cuff.
DEVICEOscillometric BP Device
Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.
DEVICEAuscultatory cuff
The auscultatory method is the gold standard for clinical blood pressure measurement. A brachial cuff is mounted and a trained healthcare provider uses a sphygmomanometer and listens for the Korotkoff sounds using a stethoscope to measure blood pressure.
Sponsors
Dynocardia, Inc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Health volunteers 18 years and above; equal numbers of males and females to address Sex As a Biological Variable (SABV); and in sinus rhythm. * Agree to commit to participate in the current protocol. * Provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).
Exclusion criteria
* Unable or unwilling to provide informed consent * Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator. * A difference of \>10 mm Hg in left versus right arm oscillometric systolic BP. * Upper extremity arteriovenous hemodialysis shunt. * Wrist distortion or pain from arthritis. * Prior trauma or surgery at the radial artery monitoring site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Diastolic Blood Pressure | up to 30 minutes | 3 sets readings compared across blood pressure (mmHg) |
| Comparison of Systolic Blood Pressure | up to 30 minutes | 3 sets readings compared across blood pressure (mmHg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Irritation | Up to 72 hours | Examining for local skin irritation |
Countries
United States
Contacts
Primary ContactMohan Thanikachalam, MD
Backup ContactGokul Prasath Rajamanickam, MS
Outcome results
None listed