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OpenTrials
Completed

NCT Number: NCT04506775

Comparison of Non-invasive and Invasive Blood Pressure Monitors

To compare a noninvasive and continuous radial artery blood pressure measurements utilizing ViTrack (developed by Dynocardia) to the standard of care radial artery catheterization, in patients undergoing surgery or those who are being cared for in the intensive care unit

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

The ViTrack is strapped over the radial artery at the wrist.The ViTrack blood pressure cuff will be utilized to obtain continuous blood pressure (BP) readings throughout the surgical procedure or intensive care unit. This will allow us to compare BP readings between the non-invasive ViTrack device and the standard of care invasive intra-arterial catheters readings. Data collection from both the ViTrack and arterial catheter occur in the opposite wrists.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients between the ages of 18 - 90 years age who are undergoing any surgery or in the intensive care unit and require intra-arterial catheterization for continuous BP measurement.
  • Patients having elective surgeries.
  • Patients having emergent surgeries, but only if research staff can have appropriate time to review study with patient and obtain signature on fact sheet prior to administration of medications that could affect coherency.
  • Patients who are able to review, verbalize understanding, and sign fact sheet. If patient has a health care proxy (HCP) or legal guardian, study will be reviewed, and signature of HCP or legal guardian will be obtained.

Exclusion criteria

  • Inability to obtain consent from the patient, HCP or legal guardian
  • Greater than 10% difference in BP measurements between both arms prior to surgery
  • Pregnant women
  • Prisoners
  • Inability to insert a radial artery catheter
  • Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator
  • Upper extremity arteriovenous haemodialysis shunt
  • Upper extremity amputation
  • Surgical position/draping precludes access to the wrist.
  • Wrist distortion or pain from arthritis
  • Prior trauma or surgery at the radial artery monitoring site

Treatment and study plan

ViTrack

Device

ViTrack is a continuous non-invasive wearable blood pressure cuff.

Radial artery catheterization

Procedure

Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.

Primary outcomes

  1. Comparison of Diastolic Blood Pressure

    Time frame: Up to 24 Hours

    255 time points compared across continuous blood pressure (mmHg)

    As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively.

  2. Comparison of Systolic Blood Pressure

    Time frame: Up to 24 Hours

    255 time points compared across continuous blood pressure (mmHg)

    As per the FDA standard ANSI/AAMI SP10:2008 or the newly adopted ISO 81060-3:2022 standard, the mean error should be <5mmHg or <6mmHg and the standard deviation should be <8mmHg or <10mmHg respectively.

Secondary outcomes

  1. Skin Irritation

    Time frame: Up to 72 hours

    Examining for local skin irritation

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Dynocardia, Inc

Registry information

Official study title

Comparison of a Standalone, Continuous, Non-invasive Blood Pressure Monitor (cNIBP) to Radial Arterial Catheterization in Patients Undergoing Surgery.

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 10, 2020
Registry last updated
Sep 10, 2025

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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