TeleradiologyNCT02271048
The Feasibility and Effectiveness Study for Tele-ultrasonography
A study testing Remote ultrasonography interpretation using the smartphone in people with Teleradiology, run by Hanyang University at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 33 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Teleradiology
- What is being tested?
- Remote ultrasonography interpretation using the smartphone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 33 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Board certified emergency physicians with a ultrasound experience of 4 years and over.
Who cannot join
- Corrected eyesight < 20/30
- Color weakness or blindness
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang university guri hospital, Department of emergency medicine
Guri-si, GyeongGido, 471-701
About this study
Official title: The Feasibility and Effectiveness Study for Clinical Application of Realtime Tele-ultrasonography Using the Smartphone
Purpose
- The investigators aim to evaluate the feasibility of remote interpretation for ultrasound images using a smartphone based realtime image transmission system.
Read more
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)
Read the detailed 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).
- Conditions
- Teleradiology
- Being tested
- Remote ultrasonography interpretation using the smartphone
- Keywords
- telemedicine, ultrasonography, echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ultrasonography interpretation using the smartphoneDevice
Also called Smartphone (A1530, iPhone 5S, USA)
The reviewers interpreted the ultrasonography images on the smartphone transmitted from the ultrasound machine in real time
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Remote ultrasonography interpretation using the smartphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for TeleradiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Changsun Kim, Hanyang University
- Investigators
- Bo Seung Kang, MD, Study director, Hanyang University Guri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271048
- Sponsor's protocol ID
- 2014-03
- Status last verified
- Apr 2015
- First submitted
- 20 Oct 2014
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22868727Sable 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.
PubMed 11773571Costa 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.
PubMed 22709977Paulus 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.
PubMed 22637653Ogedegbe 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.
PubMed 23249290McBeth 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.
PubMed 24138615Biegler 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.
PubMed 23805869Kim 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.
PubMed 26620200
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effectiveness Study for Clinical Application of Realtime Tele-ultrasonography Using the Smartphone
- ClinicalTrials.gov ID
- NCT02271048
- Acronym / sponsor ID
- 2014-03
- Conditions
- Teleradiology
- Keywords
- telemedicine, ultrasonography, echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Device: Remote ultrasonography interpretation using the smartphoneThe 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. |
| Group II | Experimental | Device: Remote ultrasonography interpretation using the smartphoneThe 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. |
Who may qualify
- Ages
- 33 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Board certified emergency physicians with a ultrasound experience of 4 years and over.
Key exclusion criteria (2 listed)
- Corrected eyesight < 20/30
- Color weakness or blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ultrasonography interpretation using the smartphoneAlso: Smartphone (A1530, iPhone 5S, USA)The reviewers interpreted the ultrasonography images on the smartphone transmitted from the ultrasound machine in real time | Device | Group I, Group II |
Primary outcome
Diagnostic performance between iPhone and LCD monitor
Time frame: within one day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
- Background: PubMed 22868727Adambounou 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.
- Background: PubMed 11773571Sable 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.
- Background: PubMed 22709977Costa 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.
- Background: PubMed 22637653Paulus 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.
- Background: PubMed 23249290Ogedegbe 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.
- Background: PubMed 24138615McBeth 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.
- Background: PubMed 23805869Biegler 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.
- Derived from this study: PubMed 26620200Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Seung Kang, MD study director
Hanyang University Guri Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ultrasonography interpretation using the smartphone in people with Teleradiology, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance between iPhone and LCD monitor (time frame: within one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02271048, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015; AzTrials last refreshed its copy on 30 Oct 2026.