跳至主要内容
临床试验/NCT02108717
NCT02108717已完成不适用

The Feasibility Study for Remote CT Reading for Suspected Acute Appendicitis Using iPhone With Remote Control System in Realtime Under the Ambient Bright.

Hanyang University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Diagnostic performance between iPhone and LCD monitor

研究概览

简要总结

  1. Purpose

- The investigators aim to evaluate the feasibility of iPhone based remote control system as a real-time remote CT reading tool for suspected appendicitis under 3G network and the suboptimal illumination. 2. Methods

  • A total of 120 abdominal CT examinations; sixty had no findings of appendicitis, while the other sixty showed signs of acute appendicitis, were selected. The 16 raters reviewed these images using an LCD monitor of the PACS workstation and also an iPhone which was connected to the PACS workstation via remote control system, grading the probability of presence of acute appendicitis on each examination by a five Likert scale.
  • The investigators will compare the diagnostic performance between two devices.

详细描述

The 16 raters were randomly divided into two groups

  • The raters in group one reviewed the CT examinations numbered from one to 60 using LCD monitor and reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit
  • The other group firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor.
  • They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.
  • The raters were 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
Basic Science
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 clinical experience of 5 years and over.

排除标准

  • •Corrected eyesight < 20/30
  • •Color weakness or blindness

研究组 & 干预措施

Group I

Experimental

The raters in this group one firstly reviewed the CT scans numbered from one to 60 using LCD monitor and after mandatory rests of 20 minutes, reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit.

They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.

干预措施: Remote CT reading using the iPhone (Device)

Group I

Experimental

The raters in this group one firstly reviewed the CT scans numbered from one to 60 using LCD monitor and after mandatory rests of 20 minutes, reviewed the remaining CT examinations numbered from 61 to 120 using iPhone with TeamViewer at their first visit.

They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.

干预措施: CT reading using LCD monitor (Device)

Group II

Experimental

The raters in this group II firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor.

They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.

干预措施: CT reading using LCD monitor (Device)

Group II

Experimental

The raters in this group II firstly reviewed the CT scans numbered from one to 60 using iPhone with TeamViewer and 61 to 120 with the LCD monitor.

They visited twice with an interval of four weeks and reviewed the CT scans using revered devices at each session.

干预措施: Remote CT reading using the iPhone (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

Diagnostic accuracy between the iPhone and the LCD monitor

时间窗: within one day

◆ Sensitivity, specificity * gold standard: The pathology report and the results of clinical follow up * grade 1, 2 and 3 = negative appendicitis findings * grade 4 and 5 = positive appendicitis findings * McNemar's test to compare the sensitivity and specificity between the iPhad and the LCD monitor

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Changsun Kim

Clinical assistant professor

Hanyang University

研究点 (1)

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