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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02108717
Other study ID # 2014-02
Secondary ID
Status Completed
Phase N/A
First received April 7, 2014
Last updated May 6, 2014
Start date April 2014
Est. completion date May 2014

Study information

Verified date May 2014
Source Hanyang University
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 33 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Device:
Remote CT reading using the iPhone

CT reading using LCD monitor


Locations

Country Name City State
Korea, Republic of Hanyang university guri hospital, Department of emergency medicine Guri GyeongGido

Sponsors (1)

Lead Sponsor Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Choi HJ, Lee JH, Kang BS. Remote CT reading using an ultramobile PC and web-based remote viewing over a wireless network. J Telemed Telecare. 2012 Jan;18(1):26-31. doi: 10.1258/jtt.2011.110412. Epub 2011 Nov 8. — View Citation

Choudhri AF, Carr TM 3rd, Ho CP, Stone JR, Gay SB, Lambert DL. Handheld device review of abdominal CT for the evaluation of acute appendicitis. J Digit Imaging. 2012 Aug;25(4):492-6. doi: 10.1007/s10278-011-9431-9. — View Citation

Park JB, Choi HJ, Lee JH, Kang BS. An assessment of the iPad 2 as a CT teleradiology tool using brain CT with subtle intracranial hemorrhage under conventional illumination. J Digit Imaging. 2013 Aug;26(4):683-90. doi: 10.1007/s10278-013-9580-0. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic performance between iPhone and LCD monitor 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 No
Primary Diagnostic accuracy between the iPhone and the LCD monitor ? 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 No
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