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NCT06171698 Clinical Trial

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

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06171698
Other study ID # IRB00281586
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2023
Est. completion date December 31, 2027

Study information
Verified date December 2023
Source Johns Hopkins University
Contact Kate Calligy, BSN
Phone 443-287-4117
Email kcummi15@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 31, 2027
Est. primary completion date March 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Research Prototype Monitor
Continuous vital sign is collected via a research prototype monitor

Locations
Country Name City State
United States Johns Hopkins Children's Center Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Feasibility of a non-invasive monitoring device 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. From device placement to removal, up to 12 hours
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