Teleradiology, UltrasonographyNCT02160509
Telementoring for Emergency Ultrasonography Performed by Emergency Physicians With Low Experience.
An observational study of Teleradiology, Ultrasonography, run by Hanyang University at 1 site in South Korea.
Trial summary
1. Purpose This study aims to evaluate the feasibility of iPhone based telementoring for the ultrasonography. 2. Methods Study Design: Prospective observational study Study Setting: Urban academic ED of tertiary care teaching hospital Study period: July, 2014 ~ December, 2014 (six months) Study participants: Of the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Teleradiology, Ultrasonography
- What is being tested?
- IPhone based realtime remote ultrasound interpretation
- Type of treatment
- Medical device
- How many people
- 103 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2014to Apr 2015
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients who undergo the ultrasonography in the emergency department
Who may be able to join
- the patients who undergo the emergency physician-performed ultrasonography
Who cannot join
- the failure of examination due to such as patients' severe obesity, a large amount of gas and etc.
- the patients who refuse to participate in this study.
- the patients who need emergency ultrasonography.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University guri hospital
Guri-si, Gyeonggi-do, 471-701
About this study
Official title: Telementoring for Emergency Ultrasonography Performed by Emergency Physicians
- Purpose
- This study aims to evaluate the feasibility of iPhone based telementoring for the ultrasonography.
- Methods
- Study Design: Prospective observational study
- Study Setting: Urban academic ED of tertiary care teaching hospital
- Study period: July, 2014 ~ December, 2014 (six months)
- Study participants: Of the patients who need to undergo ultrasonography in the ED, those who are agreed to participate in this study are enrolled.
- We hypothesize that the iPhone based real time tele-diagnosis by remote expert would not be different from the diagnosis via his/her direct ultrasound examination.
Read the detailed description
- Teleultrasound system
- We already developed the telesystem for viewing the ultrasound examinations performed in the emergency department (ED) by using the iPhone display simultaneously at the out of ED.
- Remote mentors can view the patient and examiner's hand holding the ultrasound probe while simultaneously viewing the ultrasound image in the same field of ultrasound display
- The examiner and the mentor can communicate with each other.
- Procedures:
- The residents perform the ultrasonography and the out of ED expert observe the practice by using the iPhone.
- While viewing the practice, the mentor can guide the examiner (resident) to manipulate the probe to get the best ultrasound image.
- After finishing the practice, the mentor measures the speed of used mobile network using the application of 'BENCHBEE' and records the predesigned registry.
- The registry includes the patients' information, the time and date of examination, the type of mobile network (3G, LTE, WiFi and etc.) and the speed of mobile network, used tele-displayer (iPhone, iPad, iPad mini), used probe, performed body organ (cardiac, lung, Hepatobiliary, vascular, genital organ, appendix and intestine including suspected intussusception), the examiner's level of training and the ultrasound experience of the examiner and the mentor.
- The mentor records the patient's diagnosis and the problems during this procedure.
- The mentor goes to the patient, perform the ultrasonography directly and confirm the patients' diagnosis.
- We will investigate the diagnostic accuracy for iPhone-based tele-ultrasonography comparing these diagnoses.
- Conditions
- Teleradiology, Ultrasonography
- Being tested
- IPhone based realtime remote ultrasound interpretation
- Keywords
- real time, ultrasonography, handheld
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPhone based realtime remote ultrasound interpretationDevice
Also called Application name: cubeview
| Study group | Role | What they receive |
|---|---|---|
| - The patients who undergo ultrasonography in the ED | Not described Receives: Device: IPhone based realtime remote ultrasound interpretation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy by using Receiver Operating Characteristics (area under the curve)
Comparing sensitivity and specificity between the iPhone and LCD monitor of the ultrasound machine.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Teleradiology, UltrasonographyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
- Target duration
- 6 Months
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 chair, Emergency Department of Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160509
- Sponsor's protocol ID
- 2014-01
- Status last verified
- Apr 2015
- First submitted
- 5 Jun 2014
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim C, Kang BS, Choi HJ, Lee YJ, Kang GH, Choi WJ, Kwon IH. Nationwide online social networking for cardiovascular care in Korea using Facebook. J Am Med Inform Assoc. 2014 Jan-Feb;21(1):17-22. doi: 10.1136/amiajnl-2012-001465. Epub 2013 May 23.
PubMed 23703828Park JB, Choi HJ, Lee JH, Kang BS. An assessment of the iPad 2 as a CT teleradiology tool using brain CT with subtle intracranial hemorrhage under conventional illumination. J Digit Imaging. 2013 Aug;26(4):683-90. doi: 10.1007/s10278-013-9580-0.
PubMed 23404630Lim TH, Choi HJ, Kang BS. Feasibility of dynamic cardiac ultrasound transmission via mobile phone for basic emergency teleconsultation. J Telemed Telecare. 2010;16(5):281-5. doi: 10.1258/jtt.2010.091109. Epub 2010 Jun 24.
PubMed 20576745Choi HJ, Lee JH, Kang BS. Remote CT reading using an ultramobile PC and web-based remote viewing over a wireless network. J Telemed Telecare. 2012 Jan;18(1):26-31. doi: 10.1258/jtt.2011.110412. Epub 2011 Nov 8.
PubMed 22067287Biegler 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 23805869McBeth 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 24138615
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
- Telementoring for Emergency Ultrasonography Performed by Emergency Physicians
- ClinicalTrials.gov ID
- NCT02160509
- Acronym / sponsor ID
- 2014-01
- Conditions
- Teleradiology, Ultrasonography
- Keywords
- real time, ultrasonography, handheld
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 10 Jun 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
- This study aims to evaluate the feasibility of iPhone based telementoring for the ultrasonography.
- Methods
- Study Design: Prospective observational study
- Study Setting: Urban academic ED of tertiary care teaching hospital
- Study period: July, 2014 ~ December, 2014 (six months)
- Study participants: Of the patients who need to undergo ultrasonography in the ED, those who are agreed to participate in this study are enrolled.
- We hypothesize that the iPhone based real time tele-diagnosis by remote expert would not be different from the diagnosis via his/her direct ultrasound examination.
Detailed description
- Teleultrasound system
- We already developed the telesystem for viewing the ultrasound examinations performed in the emergency department (ED) by using the iPhone display simultaneously at the out of ED.
- Remote mentors can view the patient and examiner's hand holding the ultrasound probe while simultaneously viewing the ultrasound image in the same field of ultrasound display
- The examiner and the mentor can communicate with each other.
- Procedures:
- The residents perform the ultrasonography and the out of ED expert observe the practice by using the iPhone.
- While viewing the practice, the mentor can guide the examiner (resident) to manipulate the probe to get the best ultrasound image.
- After finishing the practice, the mentor measures the speed of used mobile network using the application of 'BENCHBEE' and records the predesigned registry.
- The registry includes the patients' information, the time and date of examination, the type of mobile network (3G, LTE, WiFi and etc.) and the speed of mobile network, used tele-displayer (iPhone, iPad, iPad mini), used probe, performed body organ (cardiac, lung, Hepatobiliary, vascular, genital organ, appendix and intestine including suspected intussusception), the examiner's level of training and the ultrasound experience of the examiner and the mentor.
- The mentor records the patient's diagnosis and the problems during this procedure.
- The mentor goes to the patient, perform the ultrasonography directly and confirm the patients' diagnosis.
- We will investigate the diagnostic accuracy for iPhone-based tele-ultrasonography comparing these diagnoses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| - The patients who undergo ultrasonography in the ED | – | Device: IPhone based realtime remote ultrasound interpretation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients who undergo the ultrasonography in the emergency department
Key inclusion criteria (1 listed)
- the patients who undergo the emergency physician-performed ultrasonography
Key exclusion criteria (3 listed)
- the failure of examination due to such as patients' severe obesity, a large amount of gas and etc.
- the patients who refuse to participate in this study.
- the patients who need emergency ultrasonography.
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 |
|---|---|---|
| IPhone based realtime remote ultrasound interpretationAlso: Application name: cubeview | Device | - The patients who undergo ultrasonography in the ED |
Primary outcome
Diagnostic accuracy by using Receiver Operating Characteristics (area under the curve)
Time frame: up to 6 months
Comparing sensitivity and specificity between the iPhone and LCD monitor of the ultrasound machine.
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 23703828Kim C, Kang BS, Choi HJ, Lee YJ, Kang GH, Choi WJ, Kwon IH. Nationwide online social networking for cardiovascular care in Korea using Facebook. J Am Med Inform Assoc. 2014 Jan-Feb;21(1):17-22. doi: 10.1136/amiajnl-2012-001465. Epub 2013 May 23.
- Background: PubMed 23404630Park JB, Choi HJ, Lee JH, Kang BS. An assessment of the iPad 2 as a CT teleradiology tool using brain CT with subtle intracranial hemorrhage under conventional illumination. J Digit Imaging. 2013 Aug;26(4):683-90. doi: 10.1007/s10278-013-9580-0.
- Background: PubMed 20576745Lim TH, Choi HJ, Kang BS. Feasibility of dynamic cardiac ultrasound transmission via mobile phone for basic emergency teleconsultation. J Telemed Telecare. 2010;16(5):281-5. doi: 10.1258/jtt.2010.091109. Epub 2010 Jun 24.
- Background: PubMed 22067287Choi HJ, Lee JH, Kang BS. Remote CT reading using an ultramobile PC and web-based remote viewing over a wireless network. J Telemed Telecare. 2012 Jan;18(1):26-31. doi: 10.1258/jtt.2011.110412. Epub 2011 Nov 8.
- 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.
- 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.
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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 chair
Emergency Department of Hanyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Teleradiology, Ultrasonography, 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 3 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 accuracy by using Receiver Operating Characteristics (area under the curve) (time frame: up to 6 months). 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 NCT02160509, which also lists 6 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.