Focused Cardiac Ultrasound

NCT ID: NCT03887286

Last Updated: 2020-06-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-05-30

Brief Summary

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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

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Conditions

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Ventricular Dysfunction Pericardial Effusion Valvular Disease Septal Defect

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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treatment group

All participants to receive standard transthoracic echocardiogram and hand held echocardiogram

Group Type EXPERIMENTAL

Philips EPIQ 7 ultrasound machine

Intervention Type DEVICE

Standard transthoracic echocardiography

Philips Lumify Broadband sector array transducer

Intervention Type DEVICE

Portable hand-held ultrasound device

Interventions

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Philips EPIQ 7 ultrasound machine

Standard transthoracic echocardiography

Intervention Type DEVICE

Philips Lumify Broadband sector array transducer

Portable hand-held ultrasound device

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Mary Sokoloski

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Sokoloski, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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20181089

Identifier Type: -

Identifier Source: org_study_id

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