Non-invasive and Continuous Blood Pressure Monitoring | NCT06887465

Studies
Non-invasive and Continuous Blood Pressure Monitoring

NCT06887465

Sponsor

Vena Vitals

Status

Not yet recruiting

Last Update Posted

Apr 3, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Blood Pressure

Interventions

Non-invasive Blood Pressure Monitor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2025Estimated

Primary Completion Date

Dec 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Mar 13, 2025

First Submission Date that Met QC Criteria

Mar 13, 2025

First Posted Date

Mar 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2025

Last Update Posted Date

Apr 3, 2025Actual

Name	Class
Thomas Jefferson University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-invasive Blood Pressure Monitor	Device	Application of the VeriTrack non-invasive blood pressure monitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Blood Pressure Change Accuracy	Changes in sys, dia, and MAP measured by VeriTrack will be evaluated and compared to the changes measured by the arterial line	1-24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thomas Jefferson University		Philadelphia	Pennsylvania	19107	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided