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

NCT ID: NCT06171698

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-30

Study Completion Date

2025-06-24

Brief Summary

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

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Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Research Prototype Monitor

Group Type EXPERIMENTAL

Research Prototype Monitor

Intervention Type DEVICE

Continuous vital sign is collected via a research prototype monitor

Interventions

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Research Prototype Monitor

Continuous vital sign is collected via a research prototype monitor

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Danielle Gottlieb Sen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

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Johns Hopkins Children's Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00281586

Identifier Type: -

Identifier Source: org_study_id

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