Performance Evaluation of the ViTrack Continuous Non-invasive Blood Pressure Measurement Device

February 23, 2026 updated by: Mehmet Turan, The University of Texas Health Science Center, Houston
The purpose of this study is to calibrate the ViTrack™ arterial pressure waveform against intra-arterial pressure (IAP) in dynamic clinical settings and to assess the optimized ViTrack™ design to measure and continuously track blood pressure over a wide, clinically-relevant pressure range.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

N/A

Sampling Method

Non-Probability Sample

Study Population

subjects scheduled to undergo noncardiac surgery with likely invasive arterial pressure monitoring will be included will be included

Description

Inclusion Criteria:

  • scheduled to undergo noncardiac surgery with general or spinal anesthesia
  • clinical indication for invasive intra-arterial pressure monitoring
  • palpable pulse

Exclusion Criteria:

  • difference of greater than 10 mmHg in the left versus right arm oscillometric systolic blood pressure
  • Upper extremity arteriovenous hemodialysis shunt
  • Upper extremity amputation
  • Planned surgical position/draping that precludes access to the wrist
  • Wrist distortion or pain from arthritis
  • Prior trauma or surgery at the radial artery monitoring site
  • Unable to provide informed consent
  • Clinical contraindication as determined by the clinical team or study investigators

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ViTrack device
Device: ViTrack device
In the operating room the ViTrack™ device will be applied the wrist. Monitoring will start in the operating room and will continue throughout the surgery. The device can be worn on either wrist. It will be connected to a power unit that will capture blood pressure data and stream the data to a secure laptop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Diastolic Blood Pressure
Time Frame: From start of surgery up to 24 hours after surgery
255 time points compared across continuous blood pressure (mmHg)
From start of surgery up to 24 hours after surgery
Comparison of Systolic Blood Pressure
Time Frame: From start of surgery up to 24 hours after surgery
255 time points compared across continuous blood pressure (mmHg)
From start of surgery up to 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants who show signs of Skin Irritation
Time Frame: From start of surgery up to 72 hours after surgery
From start of surgery up to 72 hours after surgery

Collaborators and Investigators

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

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Mehmet Turan, MD, The University of Texas Health Science Center, Houston

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 (Actual)

December 17, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

December 2, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC-MS-24-0970

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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