The Feasibility and Effectiveness Study for Tele-ultrasonography

Teleradiology Clinical Trial

Official title:

The Feasibility and Effectiveness Study for Clinical Application of Realtime Tele-ultrasonography Using the Smartphone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271048
• Other study ID #: 2014-03
• Status: Completed
• Phase: N/A
• First received: October 20, 2014
• Last updated: April 16, 2015
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)

Description:

The 12 raters are randomly divided into two groups

The raters in group one review the echocardiographies examinations numbered from one to 50 using LCD monitor of ultrasound machine and review the remaining 50 examinations numbered from 51 to 100 using iPhone with CubeView at their first visit The other group firstly review echocardiography numbered from one to 50 using iPhone with CubeView and 51 to 100 with the LCD monitor.

They visit twice with an interval of four weeks and review the echocardiography examinations using revered devices at each session. They also review abdominal ultrasound images on the same plan as reviewing echocardiography.

When they review the echocardiography, the raters measure the ejection fraction by visual estimation (1=obviously normal EF, 2 = probably normal EF, 3 = unsure, 4 = probably reduced EF, 5 = obviously reduced EF). In cate of d the abdominal ultrasound, they are 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: 12
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 33 Years to 45 Years

Eligibility

Inclusion Criteria:

• Board certified emergency physicians with a ultrasound experience of 4 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: Diagnostic

Related Conditions & MeSH terms

• Teleradiology

Intervention

Device:
• Remote ultrasonography interpretation using the smartphone
The reviewers interpreted the ultrasonography images on the smartphone transmitted from the ultrasound machine in real time

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 (7)

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. French. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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