Cardiac AnomaliesPOCUS-AI PEMNCT07503158
Prospective Evaluation of Cardiac Point-of-Care Ultrasound (POCUS) Performed by PEM Fellows and Artificial Intelligence on Children With Pre-existing Cardiac Conditions.
An observational study of Cardiac Anomalies, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Cardiac Anomalies
- What is being tested?
- AI Pocus_Cardiac
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2026to 30 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Children aged 0-21 years
- Preexisting cardiac disease
- Participants are either evaluated in the ED or in the cardiology setting.
Who cannot join
- Participant's clinical condition requires immediate life-saving interventions
- New diagnosis of cardiac condition
- Preexisting cardiac abnormality documented prior to the index encounter.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paul Khalil, MD Medical Director Care Ultrasound Program, MD contact
United States1 site
Nicklaus Children's Hospital
Miami, Florida, 33155
Jenny Esteves, MBA, MHSA, LPPB, 1-786-624-2854, jenny.esteves@nicklaushealth.org
Paul Khalil, MD
About this study
Official 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
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.
Read the detailed 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.
- Conditions
- Cardiac Anomalies
- Being tested
- AI Pocus_Cardiac
- Keywords
- POCUS AI, Children
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Pocus_CardiacDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| cardiac disease illness | cardiac disease illness that can be examined at the ER Receives: Diagnostic Test: AI Pocus_Cardiac |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2026
- Study start30 Mar 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac AnomaliesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07503158
- Sponsor's protocol ID
- RDC26011
- Acronym
- POCUS-AI PEM
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Decision to share information has not been determined yet.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07503158
- Acronym / sponsor ID
- POCUS-AI PEM / RDC26011
- Conditions
- Cardiac Anomalies
- Keywords
- POCUS AI, Children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's HospitalUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 31 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac disease illness | – | Diagnostic Test: AI Pocus_Cardiaccardiac disease illness that can be examined at the ER |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- Children aged 0-21 years
- Preexisting cardiac disease
- Participants are either evaluated in the ED or in the cardiology setting.
Key exclusion criteria (3 listed)
- Participant's clinical condition requires immediate life-saving interventions
- New diagnosis of cardiac condition
- Preexisting cardiac abnormality documented prior to the index encounter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI Pocus_Cardiacassess 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. | Diagnostic test | cardiac disease illness |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Undecided. Decision to share information has not been determined yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Khalil, MD Medical Director Care Ultrasound Program, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Anomalies, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul Khalil, MD Medical Director Care Ultrasound Program, MD (1-786-624-3742, paul.khalil@nicklaushealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of pericardial effusion and LV systolic dysfunction (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.