Teleradiology Clinical Trial
Official title:
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)
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).
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02591602 -
Teleradiology Program for Frail Patients Living at Home or in Nursing-homes
|
N/A |