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NCT Number: NCT07503158

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

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.

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Key information

Age range

1 month–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location contact

Jenny Esteves, MBA, MHSA, LPPB

CONTACT

[email protected]

1-786-624-2854

Paul Khalil, MD

PRINCIPAL_INVESTIGATOR

Tomas Leng, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. presence of pericardial effusion and LV systolic dysfunction

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Khalil, MD Medical Director Care Ultrasound Program, MD

CONTACT

[email protected]

1-786-624-3742

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: POCUS-AI PEM

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 31, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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