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Completed

NCT Number: NCT02271048

The Feasibility and Effectiveness Study for Tele-ultrasonography

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)

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Key information

Conditions

Age range

33 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hanyang university guri hospital, Department of emergency medicine

Guri-si, GyeongGido, 471-701, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ultrasonography interpretation using the smartphone

Device

The reviewers interpreted the ultrasonography images on the smartphone transmitted from the ultrasound machine in real time

Other names: Smartphone (A1530, iPhone 5S, USA)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2014
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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