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

NCT07503158 | Not Yet Recruiting FDA Device

• 1 other identifier: RDC26011
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Anomalies

Keywords

POCUS AI; Children

Outcome Measures

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

  2 years

Study Arms (1)

cardiac disease illness

cardiac disease illness that can be examined at the ER

Diagnostic Test: AI Pocus_Cardiac

Interventions

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.

cardiac disease illness

Eligibility Criteria

• Age: 1 Month - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Children aged 0-21 years
• Preexisting cardiac disease
• Participants are either evaluated in the ED or in the cardiology setting.

You may not qualify if:

• Participant's clinical condition requires immediate life-saving interventions
• New diagnosis of cardiac condition
• Preexisting cardiac abnormality documented prior to the index encounter.

Sponsors & Collaborators

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital: lead

Study Sites (1)

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Paul Khalil, MD Medical Director Care Ultrasound Program, MD

CONTACT

1-786-624-3742; paul.khalil@nicklaushealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 31, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

US (1)