Non-invasive and Continuous Blood Pressure Monitoring

March 31, 2025 updated by: Vena Vitals

Comparison of Non-Invasive Wearable Sensors to Radial Arterial Catheterization on Human Subjects

The goal of this observational study is to evaluate the accuracy and reliability of the VeriTrack non-invasive blood pressure monitor compared to radial arterial catheterization in adult surgical patients.

The main question it aims to answer is:

How well does VeriTrack measure continuous blood pressure compared to an arterial catheter?

Researchers will compare VeriTrack readings to arterial line measurements to determine if the VeriTrack provides comparable accuracy and clinical utility.

Participants will wear the VeriTrack device during surgery and have a radial arterial catheter placed as part of standard care.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
        • Contact:
        • Contact:
          • Jeffrey Joseph, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgery who have an arterial line and are in supine position

Description

Inclusion Criteria:

  • Patients whose blood pressure will be monitored using an arterial line during their procedure
  • Patients who have a palpable dorsalis pedis pulse

Exclusion Criteria:

  • Patients who have non-palpable dorsalis pedis pulses
  • Patients whose limbs are inaccessible for placement of Vena Vitals Wearable
  • Patients with known allergy to adhesives and/or silicone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the VeriTrack device in continuous blood pressure monitoring
Time Frame: 1-24 hours
Systolic, diastolic, and mean arterial pressure (MAP) values will be compared between the VeriTrack and the arterial line using a Bland-Altman analysis.
1-24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood Pressure Change Accuracy
Time Frame: 1-24 hours
Changes in sys, dia, and MAP measured by VeriTrack will be evaluated and compared to the changes measured by the arterial line
1-24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vena Vitals

Collaborators

Thomas Jefferson University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 3, 2025

Last Update Submitted That Met QC Criteria

March 31, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VVAL0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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