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

May 6, 2014 updated by: Changsun Kim, Hanyang University

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

  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.

Study Overview

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • GyeongGido
      • Guri, GyeongGido, Korea, Republic of, 471-701
        • Hanyang university guri hospital, Department of emergency medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I

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.

Other Names:
  • Smartphone (A1530, iPhone 5S, USA)
Other Names:
  • LCD monitor (MX210, EIZO, Japan)
Experimental: Group II

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.

Other Names:
  • Smartphone (A1530, iPhone 5S, USA)
Other Names:
  • LCD monitor (MX210, EIZO, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within one day
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
within one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Bo Seung Kang, MD, Hanyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 6, 2014

Last Verified

May 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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