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

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

Status: Not yet enrolling

Conditions: Cardiac Anomalies

Treatments: Diagnostic Test: AI Pocus_Cardiac

Study type: Observational

Funder types: Other

Identifiers

NCT07503158

RDC26011

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 month to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

cardiac disease illness

Description:

cardiac disease illness that can be examined at the ER

Treatment:

Diagnostic Test: AI Pocus_Cardiac