Comparison of Non-invasive and Invasive Blood Pressure Monitors

NCT04506775 | Completed Results FDA Device

• 1 other identifier: H00019883
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Blood Pressure; Surgery; Intensive Care Unit

Keywords

Blood Pressure; BP; Surgery; Radial Artery Catheter

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Skin Irritation

  Up to 72 hours

Study Arms (2)

Wrist one

EXPERIMENTAL

Wrist one will have both the ViTrack wrist cuff on one wrist

Device: ViTrack

Wrist Two

ACTIVE COMPARATOR

Wrist two and the radial artery catheter in the opposite wrist.

Procedure: Radial artery catheterization

Interventions

ViTrack DEVICE

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

Wrist one

Radial artery catheterization PROCEDURE

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

Wrist Two

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Dynocardia, Inc: collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

• 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.

  PMID: 11137411 RESULT

Results Point of Contact

• Title: J. Aaron Scott, DO
• Organization: UMass Chan Medical School

jamesaaron.scott@umassmemorial.org

774-303-4156

Study Officials

• James A Scott, DO

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None, patients are their own control.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology & Perioperative Medicine

Model Details: Single group design, patients are their own control.

Study Record Dates

• First Submitted: July 13, 2020
• First Posted: August 10, 2020
• Study Start: January 1, 2020
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will become available following data analysis within 12 months of study completion and will remain available for up to 3 years.
• Access Criteria: Data will be accessed via secure methods outlined in a data sharing agreement.

Locations

US (1)