NCT02108717

Brief Summary

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2014

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 8, 2014

Status Verified

May 1, 2014

Enrollment Period

1 month

First QC Date

April 7, 2014

Last Update Submit

May 6, 2014

Conditions

Telemedicine

Keywords

Telemedicineappendicitisremote consultation

Outcome Measures

Primary Outcomes (2)

  • 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

  • Diagnostic accuracy between the iPhone and the LCD monitor

    â—† 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

Study Arms (2)

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.

Device: Remote CT reading using the iPhoneDevice: CT reading using LCD monitor

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.

Device: Remote CT reading using the iPhoneDevice: CT reading using LCD monitor

Interventions

Remote CT reading using the iPhoneDEVICE
Also known as: Smartphone (A1530, iPhone 5S, USA)
Group IGroup II
CT reading using LCD monitorDEVICE
Also known as: LCD monitor (MX210, EIZO, Japan)
Group IGroup II

Eligibility Criteria

Age33 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Board certified emergency physicians with a clinical experience of 5 years and over.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang university guri hospital, Department of emergency medicine

Guri-si, GyeongGido, 471-701, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 22067287BACKGROUND

  • 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.

    PMID: 22146833BACKGROUND

  • 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.

    PMID: 23404630BACKGROUND

  • Kim C, Kang B, Choi HJ, Park JB. A Feasibility Study of Real-Time Remote CT Reading for Suspected Acute Appendicitis Using an iPhone. J Digit Imaging. 2015 Aug;28(4):399-406. doi: 10.1007/s10278-015-9775-7.

    PMID: 25700617DERIVED

Related Links

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Study Officials

  • Bo Seung Kang, MD

    Hanyang University Guri Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

April 7, 2014

First Posted

April 9, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

May 8, 2014

Record last verified: 2014-05

Locations

KR(1)