Telementoring for Identifying the Appendix Using Telesonography (TIAT)

January 24, 2016 updated by: LEE YOON-JE, Hanyang University

A Feasibility Study of Telementoring for Identifying the Appendix Using Smartphone-based Telesonography

The investigators investigated the feasibility of the clinical application of novice-practitioner-performed/offsite-mentor-guided ultrasonography for identifying the appendix.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized cross-over study was conducted using a telesonography system that can transmit the ultrasound images displayed on the ultrasound monitor(ultrasound sequence video) and images showing the practitioner's operations(background video) to a smartphone without any interruption in motion over a Long Term Evolution (LTE) network. Thirty novice practitioners were randomly assigned to two groups. The subjects in group A (n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert, whereas those in group B (n=15) performed the same procedure under mentoring by an offsite expert.

Each subject performed the procedure on three simulated patients. After a four-week interval, they performed the procedure again under the other type of mentoring. A total of 90 ultrasound examinations were performed in each scenario. The primary outcomes were the success rate for identifying the appendix and the time required to identify the appendix.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Korea, Republic of
    • Gyeonggi-do
      • Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
        • Hanyang University Guri Hospital

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

25 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Without any experience in ultrasonography

Exclusion Criteria:

  • Subjects who do not want to participate
  • Subjects who has eye pain or any eye problem
  • Subjects who has wrist pain

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: On-site sonography
The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert.
Active Comparator: Smartphone-based Telesonography
The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an offsite expert.
Device: Smartphone-based Telesonography
The 30 participating examiners were randomly divided into two groups. In phase one, group A performed ultrasonography under onsite mentoring and group B performed the same procedure under remote mentoring. Each examiner was randomly assigned one expert and three SPs for phase one. Four weeks later, they were partnered with the same expert and SPs to whom they had been assigned in phase one and performed the procedure under the other type of mentoring (phase two). The examination order of the SPs was randomly assigned by choosing a number between one and six (1: A-B-C, 2: A-C-B, 3: B-A-C, 4: B-C-A, 5: C-A-B, 6: C-B-A) in each phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate
Time Frame: 8 months
"Success" is meaning of identifying appendix in 10 minutes.
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to identifying appendix
Time Frame: 8 months
8 months

Collaborators and Investigators

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

Sponsor

Hanyang University

Investigators

  • Principal Investigator: YOONJE LEE, M.D., Departement of Emergency Medicine, Hanyang University Guri Hospital

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

March 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 24, 2016

First Posted (Estimate)

January 28, 2016

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 24, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Hanyang University

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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