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Clinical Trials/NCT02271048
NCT02271048
Completed
Not Applicable

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

Hanyang University1 site in 1 country12 target enrollmentNovember 2014
ConditionsTeleradiology

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Teleradiology
Sponsor
Hanyang University
Enrollment
12
Locations
1
Primary Endpoint
Diagnostic performance between iPhone and LCD monitor
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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)

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).

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
March 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Changsun Kim

Clinical assistant professor

Hanyang University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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