N/A
N=47
Focused Cardiac Ultrasound
Ventricular Dysfunction · Pericardial Effusion · Valvular Disease · Septal Defect
Bottom Line
View on ClinicalTrials.gov: NCT03887286 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. — 13; 13; 9; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Philips EPIQ 7 ultrasound machine (Device); Philips Lumify Broadband sector array transducer (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. |
13; 13; 9; 4; 25; 23 | — |
Summary
To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.
Eligibility Criteria
Inclusion Criteria
- Patients presenting to pediatric cardiology clinic at Holtz Children's hospital requiring comprehensive or limited transthoracic echocardiogram.
- Willing and able to provide informed consent or assent.
- In clinically stable condition as assessed by the principal investigator..
- With adequate echocardiographic windows.
Exclusion Criteria
- Patients with poor echocardiographic windows.
- Patients who refuse informed consent.
- Pregnant women.
- Prisoners.
- Patients deemed unfit to participate in the clinical trial as assessed by the principal investigator.
Data sourced from ClinicalTrials.gov (NCT03887286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.