The Feasibility and Effectiveness Study for Tele-ultrasonography

April 16, 2015 updated by: Changsun Kim, Hanyang University

The Feasibility and Effectiveness Study for Clinical Application of Realtime Tele-ultrasonography Using the Smartphone

Purpose

- The investigators aim to evaluate the feasibility of remote interpretation for ultrasound images using a smartphone based realtime image transmission system.

Methods

A total of 100 echocardiography examinations; 50 showed the ejection fraction above 50% and remaining 50 cases showed the ejection fraction under 50%, and 100 abdominal ultrasound images; 50 had signs of acute appendicitis and the other 50 had no findings of appendicitis will be consecutively selected. The 12 raters review these original images using an LCD monitor of the ultrasound machine and also an iPhone which is connected to the ultrasound machine via remote image transmission system (CubeView, Alpinion medical system, Seoul, Korea), evaluating left ventricular systolic function (for echocardiography) by measuring the ejection fraction and grading the probability of presence of acute appendicitis on each examination by a five Likert scale.

The sensitivity and specificity between two devices will be compared and the diagnostic performance between two devices will be also compared. The image quality between two devices will be measured using the double stimulation impairment scale (DSIS)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The 12 raters are randomly divided into two groups

The raters in group one review the echocardiographies examinations numbered from one to 50 using LCD monitor of ultrasound machine and review the remaining 50 examinations numbered from 51 to 100 using iPhone with CubeView at their first visit The other group firstly review echocardiography numbered from one to 50 using iPhone with CubeView and 51 to 100 with the LCD monitor.

They visit twice with an interval of four weeks and review the echocardiography examinations using revered devices at each session. They also review abdominal ultrasound images on the same plan as reviewing echocardiography.

When they review the echocardiography, the raters measure the ejection fraction by visual estimation (1=obviously normal EF, 2 = probably normal EF, 3 = unsure, 4 = probably reduced EF, 5 = obviously reduced EF). In cate of d the abdominal ultrasound, they are instructed to rate the likelihood of the presence or absence of appendicitis in each case using a five-Likert scale (1 = obvious no appendicitis, 2 = unlikely appendicitis, 3 = unsure, 4 = likely appendicitis, 5 = obvious appendicitis).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • GyeongGido
      • Guri, GyeongGido, Korea, Republic of, 471-701
        • Hanyang university guri hospital, Department of emergency medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Board certified emergency physicians with a ultrasound experience of 4 years and over.

Exclusion Criteria:

  • Corrected eyesight < 20/30
  • Color weakness or blindness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I

The raters in this group one firstly review ultrasound images numbered from one to 50 using LCD monitor of ultrasound machine and after mandatory rests of 20 minutes, review the remaining ultrasound examinations numbered from 51 to 100 using iPhone display with CubeView at their first visit.(Remote ultrasonography interpretation using the smartphone)

They visited twice with an interval of four weeks and reviewed the ultrasound images using revered devices at each session.
Device: Remote ultrasonography interpretation using the smartphone
The reviewers interpreted the ultrasonography images on the smartphone transmitted from the ultrasound machine in real time
Other Names:
  • Smartphone (A1530, iPhone 5S, USA)
Experimental: Group II

The raters in this group II firstly review the ultrasound images numbered from one to 50 using iPhone with CubeView (Remote ultrasonography interpretation using the smartphone) and 51 to 100 with the LCD monitor.

They visited twice with an interval of four weeks and reviewed the ultrasound images using revered devices at each session.
Device: Remote ultrasonography interpretation using the smartphone
The reviewers interpreted the ultrasonography images on the smartphone transmitted from the ultrasound machine in real time
Other Names:
  • Smartphone (A1530, iPhone 5S, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance between iPhone and LCD monitor
Time Frame: within one day

Dorfman-Berbaum-Metz method with RSCORE and semi-parametric estimation of ROC indices by using the DMB-MRMC software (version 2.3, available at http://perception.radiology.uiowa.edu)

  • 95% confidence interval
  • The reviewers and cases are taken as random factors
within one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Investigators

  • Study Director: Bo Seung Kang, MD, Hanyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 22, 2014

Study Record Updates

Last Update Posted (Estimate)

April 17, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Teleradiology

Clinical Trials on Remote ultrasonography interpretation using the smartphone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe