[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631628":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":25,"overallOfficials":13,"centralContacts":31,"locations":37,"responsibleParty":62,"collaborators":13,"id":64,"slug":13,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":13,"studyType":77,"phases":13,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":84,"whyStopped":13,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Nicklaus Children's Hospital f\u002Fk\u002Fa Miami Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"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",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"COHORT","PROSPECTIVE","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.","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.",[20],{"label":21,"type":13,"description":22,"interventionNames":23},"cardiac disease illness","cardiac disease illness that can be examined at the ER",[24],"Diagnostic Test: AI Pocus_Cardiac",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":13},"DIAGNOSTIC_TEST","AI Pocus_Cardiac","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.",[21],[32],{"name":33,"role":34,"phone":35,"phoneExt":13,"email":36},"Paul Khalil, MD Medical Director Care Ultrasound Program, MD","CONTACT","1-786-624-3742","paul.khalil@nicklaushealth.org",[38],{"facility":39,"status":13,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Nicklaus Children's Hospital","Miami","Florida","33155","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-80.19366,25.77427,{"lat":49,"lon":48},[52,56,59],{"name":53,"role":34,"phone":54,"phoneExt":13,"email":55},"Jenny Esteves, MBA, MHSA, LPPB","1-786-624-2854","jenny.esteves@nicklaushealth.org",{"name":57,"role":58,"phone":13,"phoneExt":13,"email":13},"Paul Khalil, MD","PRINCIPAL_INVESTIGATOR",{"name":60,"role":61,"phone":13,"phoneExt":13,"email":13},"Tomas Leng, MD","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100631628",false,"NCT07503158","Prospective Evaluation of Cardiac Point-of-Care Ultrasound (POCUS) Performed by PEM Fellows and Artificial Intelligence on Children With Pre-existing Cardiac Conditions.","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","POCUS-AI PEM","Inclusion Criteria:\n\n* Children aged 0-21 years\n* Preexisting cardiac disease\n* Participants are either evaluated in the ED or in the cardiology setting.\n\nExclusion Criteria:\n\n* Participant's clinical condition requires immediate life-saving interventions\n* New diagnosis of cardiac condition\n* Preexisting cardiac abnormality documented prior to the index encounter.","ALL","1 Month","21 Years",{"count":75,"type":76},200,"ESTIMATED","OBSERVATIONAL","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.",[80],"Cardiac Anomalies",[82,83],"POCUS AI","Children","NOT_YET_RECRUITING","2026-04-02",{"date":87,"type":88},"2026-04-08","ACTUAL",{"date":90,"type":76},"2026-03-30",{"date":92,"type":76},"2028-03-30",{"name":5,"class":6},1]