The Feasibility and Effectiveness Study for Tele-ultrasonography

NCT02271048 | Completed DMC

• 1 other identifier: 2014-03
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose \- The investigators aim to evaluate the feasibility of remote interpretation for ultrasound images using a smartphone based realtime image transmission system. Methods A total of 100 echocardiography examinations; 50 showed the ejection fraction above 50% and remaining 50 cases showed the ejection fraction under 50%, and 100 abdominal ultrasound images; 50 had signs of acute appendicitis and the other 50 had no findings of appendicitis will be consecutively selected. The 12 raters review these original images using an LCD monitor of the ultrasound machine and also an iPhone which is connected to the ultrasound machine via remote image transmission system (CubeView, Alpinion medical system, Seoul, Korea), evaluating left ventricular systolic function (for echocardiography) by measuring the ejection fraction and grading the probability of presence of acute appendicitis on each examination by a five Likert scale. The sensitivity and specificity between two devices will be compared and the diagnostic performance between two devices will be also compared. The image quality between two devices will be measured using the double stimulation impairment scale (DSIS)

Conditions

Teleradiology

Keywords

telemedicine; ultrasonography; echocardiography

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group I

EXPERIMENTAL

The raters in this group one firstly review ultrasound images numbered from one to 50 using LCD monitor of ultrasound machine and after mandatory rests of 20 minutes, review the remaining ultrasound examinations numbered from 51 to 100 using iPhone display with CubeView at their first visit.(Remote ultrasonography interpretation using the smartphone) They visited twice with an interval of four weeks and reviewed the ultrasound images using revered devices at each session.

Device: Remote ultrasonography interpretation using the smartphone

Group II

EXPERIMENTAL

The raters in this group II firstly review the ultrasound images numbered from one to 50 using iPhone with CubeView (Remote ultrasonography interpretation using the smartphone) and 51 to 100 with the LCD monitor. They visited twice with an interval of four weeks and reviewed the ultrasound images using revered devices at each session.

Device: Remote ultrasonography interpretation using the smartphone

Interventions

Remote ultrasonography interpretation using the smartphone DEVICE

The reviewers interpreted the ultrasonography images on the smartphone transmitted from the ultrasound machine in real time

Also known as: Smartphone (A1530, iPhone 5S, USA)

Group I; Group II

Eligibility Criteria

• Age: 33 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Board certified emergency physicians with a ultrasound experience of 4 years and over.

You may not qualify if:

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

Sponsors & Collaborators

• Hanyang University: lead

Study Sites (1)

Hanyang university guri hospital, Department of emergency medicine

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

Location

Related Publications (8)

• Adambounou K, Farin F, Boucher A, Adjenou KV, Gbeassor M, N'dakena K, Vincent N, Arbeille P. [System of telesonography with synchronous teleconsultations and asynchronous telediagnoses (Togo)]. Med Sante Trop. 2012 Jan-Mar;22(1):54-60. doi: 10.1684/mst.2012.0002. French.

  PMID: 22868727 BACKGROUND

• Sable CA, Cummings SD, Pearson GD, Schratz LM, Cross RC, Quivers ES, Rudra H, Martin GR. Impact of telemedicine on the practice of pediatric cardiology in community hospitals. Pediatrics. 2002 Jan;109(1):E3. doi: 10.1542/peds.109.1.e3.

  PMID: 11773571 BACKGROUND

• Costa C, Oliveira JL. Telecardiology through ubiquitous internet services. Int J Med Inform. 2012 Sep;81(9):612-21. doi: 10.1016/j.ijmedinf.2012.05.011. Epub 2012 Jun 17.

  PMID: 22709977 BACKGROUND

• Paulus YM, Thompson NP. Inexpensive, realtime tele-ultrasound using a commercial, web-based video streaming device. J Telemed Telecare. 2012 Jun;18(4):185-8. doi: 10.1258/jtt.2012.110112. Epub 2012 May 25.

  PMID: 22637653 BACKGROUND

• Ogedegbe C, Morchel H, Hazelwood V, Chaplin WF, Feldman J. Development and evaluation of a novel, real time mobile telesonography system in management of patients with abdominal trauma: study protocol. BMC Emerg Med. 2012 Dec 18;12:19. doi: 10.1186/1471-227X-12-19.

  PMID: 23249290 BACKGROUND

• McBeth P, Crawford I, Tiruta C, Xiao Z, Zhu GQ, Shuster M, Sewell L, Panebianco N, Lautner D, Nicolaou S, Ball CG, Blaivas M, Dente CJ, Wyrzykowski AD, Kirkpatrick AW. Help is in your pocket: the potential accuracy of smartphone- and laptop-based remotely guided resuscitative telesonography. Telemed J E Health. 2013 Dec;19(12):924-30. doi: 10.1089/tmj.2013.0034. Epub 2013 Oct 19.

  PMID: 24138615 BACKGROUND

• Biegler N, McBeth PB, Tiruta C, Hamilton DR, Xiao Z, Crawford I, Tevez-Molina M, Miletic N, Ball CG, Pian L, Kirkpatrick AW. The feasibility of nurse practitioner-performed, telementored lung telesonography with remote physician guidance - 'a remote virtual mentor'. Crit Ultrasound J. 2013 Jun 27;5(1):5. doi: 10.1186/2036-7902-5-5.

  PMID: 23805869 BACKGROUND

• Kim C, Cha H, Kang BS, Choi HJ, Lim TH, Oh J. A Feasibility Study of Smartphone-Based Telesonography for Evaluating Cardiac Dynamic Function and Diagnosing Acute Appendicitis with Control of the Image Quality of the Transmitted Videos. J Digit Imaging. 2016 Jun;29(3):347-56. doi: 10.1007/s10278-015-9849-6.

  PMID: 26620200 DERIVED

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: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 17, 2015

Record last verified: 2015-04

Locations

KR (1)