Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices

Dynocardia, Inc91 enrolled

Overview

(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.

(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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hypertension Healthy

Interventions

ViTrackDEVICE

ViTrack is a continuous non-invasive wearable blood pressure cuff.

Oscillometric BP DeviceDEVICE

Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.

Auscultatory cuffDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dynocardia Inc

Newton, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Comparison of Diastolic Blood Pressure

3 sets readings compared across blood pressure (mmHg)

Time frame: up to 30 minutes

Comparison of Systolic Blood Pressure

3 sets readings compared across blood pressure (mmHg)

Time frame: up to 30 minutes

Secondary Outcomes

Skin Irritation

Examining for local skin irritation

Time frame: Up to 72 hours

Central Contacts

Mohan Thanikachalam, MD

CONTACT

+1 (617) 639 - 5569 admin@dynocardia.care

Gokul Prasath Rajamanickam, MS

CONTACT

gokulpr@dynocardia.care

Data from ClinicalTrials.gov

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