Pericardial Effusion, Septal Defect, Valvular Disease, Ventricular Dysfunction
Conditions
Brief 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.
Interventions
DEVICEPhilips EPIQ 7 ultrasound machine
Standard transthoracic echocardiography
DEVICEPhilips Lumify Broadband sector array transducer
Portable hand-held ultrasound device
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | Day 1 | Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group All participants to receive standard transthoracic echocardiogram and hand held echocardiogram
Philips EPIQ 7 ultrasound machine: Standard transthoracic echocardiography
Philips Lumify Broadband sector array transducer: Portable hand-held ultrasound device | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Treatment Group | — |
|---|---|---|
| Age, Continuous | 7.8 years STANDARD_DEVIATION 8.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 28 Participants | — |
| weight | 27.24 kg STANDARD_DEVIATION 23.41 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 47 |
| other Total, other adverse events | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 |
Outcome results
Primary
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies.
Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography
Time frame: Day 1
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Transthoracic Echocardiogram Intervention | Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | normal anatomy | 13 Participants |
| Standard Transthoracic Echocardiogram Intervention | Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | minor cardiac abnormality | 9 Participants |
| Standard Transthoracic Echocardiogram Intervention | Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | major cardiac abnormality | 25 Participants |
| Hand Held Echocardiography | Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | normal anatomy | 13 Participants |
| Hand Held Echocardiography | Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | minor cardiac abnormality | 4 Participants |
| Hand Held Echocardiography | Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies. | major cardiac abnormality | 23 Participants |