Skip to content

The Feasibility and Effectiveness Study for Tele-ultrasonography

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02271048
Enrollment
12
Registered
2014-10-22
Start date
2014-11-30
Completion date
2015-03-31
Last updated
2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Teleradiology

Keywords

telemedicine, ultrasonography, echocardiography

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).

Interventions

DEVICERemote ultrasonography interpretation using the smartphone

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

Sponsors

Hanyang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
33 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performance between iPhone and LCD monitorwithin one dayDorfman-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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026