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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-21
SponsorNicklaus Children's Hospital f/k/a Miami Children's Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: cardiac disease illness1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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