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

Not Applicable

Active, not recruiting

• Conditions: Congenital Heart Disease
• Interventions: Device: Research Prototype Monitor

• Registration Number: NCT06171698
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-30
• Study First Submitted: 2023-11-28
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-03-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Research Prototype Monitor	Research Prototype Monitor	-

Primary Outcome Measures

Name	Time	Method
Feasibility of a non-invasive monitoring device	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.

Trial Locations

Locations (1)

Johns Hopkins Children's Center; 🇺🇸 Baltimore, Maryland, United States