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NCT Number: NCT06719518

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

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.

Recruiting

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Key information

Conditions

Blood Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Number of participants who show signs of Skin Irritation

    Time frame: From start of surgery up to 72 hours after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Turan, MD

CONTACT

[email protected]

(713) 500-6251

Mohammad Khudirat

CONTACT

[email protected]

(713) 500-5558

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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