The Feasibility and Effectiveness Study for Clinical Application of Realtime Tele-ultrasonography Using the Smartphone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Diagnostic performance between iPhone and LCD monitor
研究概览
简要总结
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)
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 33 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Board certified emergency physicians with a ultrasound experience of 4 years and over.
排除标准
- •Corrected eyesight < 20/30
- •Color weakness or blindness
研究组 & 干预措施
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.
干预措施: Remote ultrasonography interpretation using the smartphone (Device)
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.
干预措施: Remote ultrasonography interpretation using the smartphone (Device)
结局指标
主要结局
Diagnostic performance between iPhone and LCD monitor
时间窗: 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
次要结局
未报告次要终点
研究者
Changsun Kim
Clinical assistant professor
Hanyang University