Non-invasive and Continuous Blood Pressure Monitoring

NCT06887465 | Not Yet Recruiting

• 1 other identifier: VVAL0001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the accuracy and reliability of the VeriTrack non-invasive blood pressure monitor compared to radial arterial catheterization in adult surgical patients. The main question it aims to answer is: How well does VeriTrack measure continuous blood pressure compared to an arterial catheter? Researchers will compare VeriTrack readings to arterial line measurements to determine if the VeriTrack provides comparable accuracy and clinical utility. Participants will wear the VeriTrack device during surgery and have a radial arterial catheter placed as part of standard care.

Conditions

Blood Pressure

Keywords

Blood pressure monitoring; Non-invasive Blood Pressure Monitoring

Outcome Measures

Primary Outcomes (1)

• Accuracy of the VeriTrack device in continuous blood pressure monitoring

  Systolic, diastolic, and mean arterial pressure (MAP) values will be compared between the VeriTrack and the arterial line using a Bland-Altman analysis.

  1-24 hours

Secondary Outcomes (1)

• Blood Pressure Change Accuracy

  1-24 hours

Interventions

Non-invasive Blood Pressure Monitor DEVICE

Application of the VeriTrack non-invasive blood pressure monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing surgery who have an arterial line and are in supine position

You may qualify if:

• Patients whose blood pressure will be monitored using an arterial line during their procedure
• Patients who have a palpable dorsalis pedis pulse

You may not qualify if:

• Patients who have non-palpable dorsalis pedis pulses
• Patients whose limbs are inaccessible for placement of Vena Vitals Wearable
• Patients with known allergy to adhesives and/or silicone

Sponsors & Collaborators

• Vena Vitals: lead
• Thomas Jefferson University: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: June 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

US (1)