Focused Cardiac Ultrasound

Ventricular Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887286
• Other study ID #: 20181089
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: May 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Pericardial Effusion
• Septal Defect
• Valvular Disease
• Ventricular Dysfunction

Intervention

Device:
• Philips EPIQ 7 ultrasound machine
Standard transthoracic echocardiography
• Philips Lumify Broadband sector array transducer
Portable hand-held ultrasound device

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	Day 1