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

Prospective Evaluation of Cardiac Point-of-Care Ultrasound (POCUS) Performed by PEM Fellows and Artificial Intelligence Interpretation Compared With a Complete Echocardiography in Children With Preexisting Cardiac Disease

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07503158

Acronym

POCUS-AI PEM

Enrollment

200

Registered

2026-03-31

Start date

2026-03-30

Completion date

2028-03-30

Last updated

2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Anomalies

Keywords

POCUS AI, Children

Brief 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.

Detailed description

Investigators hypothesize that PEM fellow-performed cardiac POCUS, when supported by AI analysis for LV dysfunction, will demonstrate diagnostic accuracy comparable to complete echocardiogram interpretation in identifying (1) pericardial effusion and (2) left ventricular systolic dysfunction in children with preexisting cardiac disease. Investigators anticipate that AI will improve accuracy and image interpretation confidence among trainees. Prospective evaluation of this method may influence future ED workflows, enhance resource utilization, support training pathways, and potentially reduce time to diagnosis in this high-risk pediatric population.

Interventions

DIAGNOSTIC_TESTAI Pocus_Cardiac

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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 21 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
presence of pericardial effusion and LV systolic dysfunction	2 years	Diagnostic test characteristics (sensitivity, specificity, predictive values, and the Kappa statistic) for PEM fellow interpretation and AI interpretation will be calculated using complete echocardiography as the reference standard

Countries

United States

Contacts

CONTACTPaul Khalil, MD Medical Director Care Ultrasound Program, MD

paul.khalil@nicklaushealth.org1-786-624-3742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026