Prospective Evaluation of Cardiac Point-of-Care Ultrasound (POCUS) Performed by PEM Fellows and Artificial Intelligence on Children With Pre-existing Cardiac Conditions.

Part of paid clinical trials in Miami, Florida.

Sponsor
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Study ID
NCT07503158
Status
Not Yet Recruiting

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Conditions

  • Cardiac Anomalies

Eligibility Criteria

Sex
ALL
Age
1 Month - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • AI Pocus_Cardiac — DIAGNOSTIC_TEST
    assess the diagnostic agreement of PEM fellow-performed cardiac POCUS and of AI-assisted interpretation using the Exo Iris probe, as compared to a complete echocardiography for detecting left ventricular (LV) systolic dysfunction and pericardial effusion in children with preexisting cardiac disease who present to the Emergency Department (ED) and are evaluated in the cardiology setting.

Study Details

The goal of this study is to prospectively assess the diagnostic agreement of PEM fellow-performed cardiac POCUS and of AI-assisted interpretation using the Exo Iris probe, as compared to a complete echocardiography for detecting left ventricular (LV) systolic dysfunction and pericardial effusion in children with preexisting cardiac disease.

Key Dates

Start date
Mar 30, 2026
Status verified
Mar 2026
Primary completion
Feb 1, 2028
Completion
Mar 30, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: cardiac disease illness
    cardiac disease illness that can be examined at the ER

Primary Outcome Measure

presence of pericardial effusion and LV systolic dysfunction [ Time Frame: 2 years ]

Central Contacts

  • Paul Khalil, MD Medical Director Care Ultrasound Program, MD
    1-786-624-3742

Locations (1)

FacilityCityStateZIPSite coordinators
Nicklaus Children's HospitalMiamiFlorida33155
Jenny Esteves, MBA, MHSA, LPPB
1-786-624-2854
Paul Khalil, MD (PRINCIPAL_INVESTIGATOR)
Tomas Leng, MD (SUB_INVESTIGATOR)

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