Nicklaus Children's Hospital
Miami, Florida, 33155, United States
Location contact
Jenny Esteves, MBA, MHSA, LPPB
CONTACT
Paul Khalil, MD
PRINCIPAL_INVESTIGATOR
Tomas Leng, MD
SUB_INVESTIGATOR
NCT Number: NCT07503158
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.
Trial opening soon.
Get Notified1 month–21 year
All sexes
Observational
Miami, Florida, 33155, United States
Jenny Esteves, MBA, MHSA, LPPB
CONTACT
Paul Khalil, MD
PRINCIPAL_INVESTIGATOR
Tomas Leng, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Contact information is provided by the study sponsor or research team.
Paul Khalil, MD Medical Director Care Ultrasound Program, MD
CONTACT
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Other
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
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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