Back to resultsFocused Cardiac Ultrasound
Primary Purpose
Ventricular Dysfunction, Pericardial Effusion, Valvular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Philips EPIQ 7 ultrasound machine
Philips Lumify Broadband sector array transducer
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventricular Dysfunction
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.
Sites / Locations
- Jackson Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment group
Arm Description
All participants to receive standard transthoracic echocardiogram and hand held echocardiogram
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03887286
Brief Title
Focused Cardiac Ultrasound
Official Title
Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Dysfunction, Pericardial Effusion, Valvular Disease, Septal Defect
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
All participants to receive standard transthoracic echocardiogram and hand held echocardiogram
Intervention Type
Device
Intervention Name(s)
Philips EPIQ 7 ultrasound machine
Intervention Description
Standard transthoracic echocardiography
Intervention Type
Device
Intervention Name(s)
Philips Lumify Broadband sector array transducer
Intervention Description
Portable hand-held ultrasound device
Primary Outcome Measure Information:
Title
Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies.
Description
Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography
Time Frame
Day 1
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Sokoloski, M.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Focused Cardiac Ultrasound
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