Prospective Measurement of Impedance During Cardiac Catheterization to Build a Non-Invasive Cardiac Output Algorithm

Johns Hopkins University1 site in 1 country60 target enrollmentMarch 30, 2023

ConditionsCongenital Heart Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Congenital Heart Disease
Sponsor: Johns Hopkins University
Enrollment: 60
Locations: 1
Primary Endpoint: Feasibility of a non-invasive monitoring device
Status: Withdrawn
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospectively measure impedance during cardiac catheterization to build a cardiac output algorithm.

Registry

clinicaltrials.gov

Start Date

March 30, 2023

End Date

June 24, 2025

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Johns Hopkins University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Scheduled to undergo cardiac catheterization with cardiac output measurement and Fick
•Planned to undergo general anesthesia for cardiac catheterization standard of care
•Parent/Guardian able to provide informed consent

Exclusion Criteria

•Not planned for standard of care general anesthesia for cardiac catheterization

Outcomes

Primary Outcomes

Feasibility of a non-invasive monitoring device

Time Frame: From device placement to removal, up to 12 hours

Feasibility of a non-invasive monitoring device that can accurately measure cardiac output in patients with congenital heart disease as determined by percent error compared to catheter-measured cardiac output.