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Completed

NCT Number: NCT02108717

The Feasibility Study for Real-time Remote CT Reading for Suspected Acute Appendicitis Using iPhone

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.

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Key information

Conditions

Telemedicine Appendicitis Cecal Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intraabdominal Infections

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 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).

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 clinical experience of 5 years and over.

Exclusion criteria

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

Treatment and study plan

Remote CT reading using the iPhone

Device

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

CT reading using LCD monitor

Device

Other names: LCD monitor (MX210, EIZO, Japan)

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

  2. Diagnostic accuracy between the iPhone and the LCD monitor

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hanyang University

Other

Registry information

Official study title

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

Acronym: Telemedicine

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
May 8, 2014

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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