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

Study Overview
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Brief Summary
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(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
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(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.

Official Title
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Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure

Conditions
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Hypertension, Healthy

Intervention / Treatment
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* Device: ViTrack
* Device: Oscillometric BP Device
* Device: Auscultatory cuff


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental-Arm<br>For the same subject, ViTrack wrist cuff is applied on one of the wrist Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm Auscultatory cuff is applied to the brachial artery of the same arm | Device: ViTrack<br>* ViTrack is a continuous non-invasive wearable blood pressure cuff.<br>Device: Oscillometric BP Device<br>* Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.<br>Device: Auscultatory cuff<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Diastolic Blood Pressure | 3 sets readings compared across blood pressure (mmHg) | up to 30 minutes | 
| Comparison of Systolic Blood Pressure | 3 sets readings compared across blood pressure (mmHg) | up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Irritation | Examining for local skin irritation | Up to 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Pressure, Cuff less, Wearable, BP