Telementoring for Emergency Ultrasonography Performed by... | NCT02160509

Studies
Telementoring for Emergency Ultrasonography Performed by Emergency Physicians With Low Experience.

NCT02160509

Sponsor

Hanyang University

Status

Completed

Last Update Posted

Apr 17, 2015Estimated

Enrollment

103Actual

Phase

Not provided

Conditions

Teleradiology, Ultrasonography

Interventions

IPhone based realtime remote ultrasound interpretation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Apr 2015Actual

First Submitted Date

Jun 5, 2014

First Submission Date that Met QC Criteria

Jun 8, 2014

First Posted Date

Jun 10, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2015

Last Update Posted Date

Apr 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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
1. 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.
2. 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
3. The examiner and the mentor can communicate with each other.
Procedures:
1. The residents perform the ultrasonography and the out of ED expert observe the practice by using the iPhone.
2. While viewing the practice, the mentor can guide the examiner (resident) to manipulate the probe to get the best ultrasound image.
3. After finishing the practice, the mentor measures the speed of used mobile network using the application of 'BENCHBEE' and records the predesigned registry.
4. 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.
5. The mentor records the patient's diagnosis and the problems during this procedure.
6. The mentor goes to the patient, perform the ultrasonography directly and confirm the patients' diagnosis.
7. We will investigate the diagnostic accuracy for iPhone-based tele-ultrasonography comparing these diagnoses.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
- The patients who undergo ultrasonography in the ED			Device: IPhone based realtime remote ultrasound interpretation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IPhone based realtime remote ultrasound interpretation	Device		- The patients who undergo ultrasonography in the ED	Application name: cubeview

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the patients who undergo the emergency physician-performed ultrasonography

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The patients who undergo the ultrasonography in the emergency department

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bo Seung Kang, MD	Emergency Department of Hanyang University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University guri hospital		Guri-si	Gyeonggi-do	471-701	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23703828	Background	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.
23404630	Background	Park 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.