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

N/ANot Yet RecruitingNCT07503158

Nicklaus Children's Hospital f/k/a Miami Children's Hospital200 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Cardiac Anomalies

Interventions

AI Pocus_CardiacDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 21 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

presence of pericardial effusion and LV systolic dysfunction

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

Time frame: 2 years