Focused Cardiac Ultrasound

Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Dysfunction; Pericardial Effusion; Septal Defect; Valvular Disease
• Intervention / Treatment: Device: Philips EPIQ 7 ultrasound machine; Device: Philips Lumify Broadband sector array transducer

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: treatment group; All participants to receive standard transthoracic echocardiogram and hand held echocardiogram	Device: Philips EPIQ 7 ultrasound machine; Standard transthoracic echocardiography; Device: Philips Lumify Broadband sector array transducer; Portable hand-held ultrasound device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Mary Sokoloski, M.D., University of Miami

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ACTUAL): May 30, 2019
• Study Completion (ACTUAL): May 30, 2019

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 16, 2020
• Last Update Submitted That Met QC Criteria: May 30, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Pericardial Effusion
• Other Study ID Numbers: 20181089

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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