Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure
Dynocardia, Inc
91 participants
Jan 1, 2021
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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.
Interventions
ViTrack is a continuous non-invasive wearable blood pressure cuff.
Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04835857