Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ViTrack, Oscillometric BP Device, Auscultatory cuff.
- Who it may be relevant to
- Registry conditions: Hypertension, Healthy. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure
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.
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
- Device ViTrack
ViTrack is a continuous non-invasive wearable blood pressure cuff. - Device Oscillometric BP Device
Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings. - Device Auscultatory 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.
Primary outcome measures
- Comparison of Diastolic Blood Pressure [Time frame: up to 30 minutes]
- Comparison of Systolic Blood Pressure [Time frame: up to 30 minutes]
Secondary outcome measures (1)
- Skin Irritation [Time frame: Up to 72 hours]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Dynocardia Inc — Newton
Identifiers
NCT: NCT04835857 · TBPI001