About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children aged 0-21 years
Preexisting cardiac disease
Participants are either evaluated in the ED or in the cardiology setting.
Disqualifiers
Participant's clinical condition requires immediate life-saving interventions
New diagnosis of cardiac condition
Preexisting cardiac abnormality documented prior to the index encounter.
Trial population
Children aged 0-21 years with preexisting cardiac disease will be for inclusion if participants are either evaluated in the ED or in the cardiology setting. Eligible ED patients will undergo cardiac POCUS and AI assessment as part of participant's clinical assessment, while participants evaluated in the cardiology setting will undergo fellow-performed cardiac POCUS with concurrent AI-based image assessment as part of the study protocol.
Trial design
Cohort
Prospective
Treatments tested in this trial
AI Pocus_Cardiac
Diagnostic testassess 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.
Treatment groups
Trial 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
Sponsors and contacts
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