Comparison of Non-invasive and Invasive Blood Pressure Monitors

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

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

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Surgery; Intensive Care Unit
• Intervention / Treatment: Device: ViTrack; Procedure: Radial artery catheterization

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Wrist one; Wrist one will have both the ViTrack wrist cuff on one wrist	Device: ViTrack; ViTrack is a continuous non-invasive wearable blood pressure cuff.
Active Comparator: Wrist Two; Wrist two and the radial artery catheter in the opposite wrist.	Procedure: Radial artery catheterization; Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Diastolic Blood Pressure	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.	Up to 24 Hours
Comparison of Systolic Blood Pressure	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.	Up to 24 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin Irritation	Examining for local skin irritation	Up to 72 hours

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Dynocardia, Inc
• Investigators: Principal Investigator: James A Scott, DO, University of Massachusetts, Worcester

Publications and helpful links

General Publications

• Heard SO, Lisbon A, Toth I, Ramasubramanian R. An evaluation of a new continuous blood pressure monitoring system in critically ill patients. J Clin Anesth. 2000 Nov;12(7):509-18. doi: 10.1016/s0952-8180(00)00201-4.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): April 18, 2024
• Study Completion (Actual): April 18, 2024

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Surgery; BP; Blood Pressure; Radial Artery Catheter
• Other Study ID Numbers: H00019883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results and de-identified data will be securely shared with the sponsor. Sponsor may only see subject initials and study ID #. All other data will de-identified for review purposes and transferred via a secure method following the universities data sharing agreement with the sponsor.
• IPD Sharing Time Frame: Data will become available following data analysis within 12 months of study completion and will remain available for up to 3 years.
• IPD Sharing Access Criteria: Data will be accessed via secure methods outlined in a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

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.: Yes