Telementoring for Identifying the Appendix Using Telesonography

NCT ID: NCT02665767

Last Updated: 2016-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Appendix, Ultrasonography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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On-site sonography

The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an onsite expert.

Group Type NO_INTERVENTION

No interventions assigned to this group

Smartphone-based Telesonography

The subjects(n=15) performed ultrasonography for the identification of the appendix under mentoring by an offsite expert.

Group Type ACTIVE_COMPARATOR

Smartphone-based Telesonography

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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LEE YOON-JE

Fellowship, Emergency Medincine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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YOONJE LEE, M.D.

Role: PRINCIPAL_INVESTIGATOR

Departement of Emergency Medicine, Hanyang University Guri Hospital

Locations

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Hanyang University Guri Hospital

Guri-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Hanyang University

Identifier Type: -

Identifier Source: org_study_id

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