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

NCT06719518 | Recruiting FDA Device

• 1 other identifier: HSC-MS-24-0970
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Pressure

Keywords

ViTrack; blood pressure monitoring

Outcome Measures

Primary Outcomes (2)

• Comparison of Diastolic Blood Pressure

  255 time points compared across continuous blood pressure (mmHg)

  From start of surgery up to 24 hours after surgery

• Comparison of Systolic Blood Pressure

  255 time points compared across continuous blood pressure (mmHg)

  From start of surgery up to 24 hours after surgery

Secondary Outcomes (1)

• Number of participants who show signs of Skin Irritation

  From start of surgery up to 72 hours after surgery

Study Arms (1)

ViTrack device

Device: ViTrack device

Interventions

ViTrack device 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

ViTrack device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Study Officials

• Mehmet Turan, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Turan, MD

CONTACT

(713) 500-6251; Mehmet.A.Turan@uth.tmc.edu

Mohammad Khudirat

CONTACT

(713) 500-5558; Mohammad.Khudirat@uth.tmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: December 17, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)