Focused Cardiac Ultrasound

Not Applicable

Completed

• Conditions: Pericardial Effusion; Septal Defect; Ventricular Dysfunction; Valvular Disease
• Interventions: Device: Philips EPIQ 7 ultrasound machine; Device: Philips Lumify Broadband sector array transducer

• Registration Number: NCT03887286
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Study Start: 2019-04-01
• Primary Completion: 2019-05-30
• Study Completion: 2019-05-30
• Status Verified: 2020-05
• Results First Submitted: 2020-05-30
• Results First Submitted QC: 2020-05-30
• Last Update Submitted: 2020-05-30
• Results First Posted: 2020-06-16
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
treatment group	Philips EPIQ 7 ultrasound machine	All participants to receive standard transthoracic echocardiogram and hand held echocardiogram
treatment group	Philips Lumify Broadband sector array transducer	All participants to receive standard transthoracic echocardiogram and hand held echocardiogram

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States