Not Yet RecruitingNot Applicable

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

United States200 participantsStarted 2026-03-30

Plain-language summary

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.

Who can participate

Age range1 Month – 21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children aged 0-21 years * Preexisting cardiac disease * Participants are either evaluated in the ED or in the cardiology setting. Exclusion Criteria: * Participant's clinical condition requires immediate life-saving interventions * New diagnosis of cardiac condition * Preexisting cardiac abnormality documented prior to the index encounter.

What they're measuring

presence of pericardial effusion and LV systolic dysfunction

Timeframe: 2 years

Trial details

NCT IDNCT07503158

SponsorNicklaus Children's Hospital f/k/a Miami Children's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-02-01

Contact for this trial

Paul Khalil, MD Medical Director Care Ultrasound Program, MD

1-786-624-3742 paul.khalil@nicklaushealth.org

View on ClinicalTrials.gov More Cardiac Anomalies trials