NCT04506775

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Blood Pressure
• Surgery
• Intensive Care Unit

Interventions

Type	Name	Description
DEVICE	ViTrack	ViTrack is a continuous non-invasive wearable blood pressure cuff.
PROCEDURE	Radial artery catheterization	Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-04-18
• Completion: 2024-04-18
• First posted: 2020-08-10
• Last updated: 2025-09-10
• Results posted: 2025-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study