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

Dynocardia

Status: Enrolling

Conditions: Hypertension; Healthy

Treatments: Device: Auscultatory cuff; Device: Oscillometric BP Device; Device: ViTrack

Study type: Observational

Funder types: Industry

Identifiers

NCT04835857

TBPI001

Details and patient eligibility

About

(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.

Full 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.

Enrollment: 91 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

91 participants in 1 patient group

Experimental-Arm

Description:

For the same subject, 1. ViTrack wrist cuff is applied on one of the wrist 2. Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm 3. Auscultatory cuff is applied to the brachial artery of the same arm

Treatment:

Device: ViTrack

Device: Oscillometric BP Device

Device: Auscultatory cuff