Telesonography for Visually Estimating Ejection Fraction

Heart Failure, Systolic Clinical Trial

Official title:

Can Offsite Expert Accurately Estimate the Ejection Fraction by Watching and Instructing the Onsite Novice Sonographer's Practice Via the Social Network System?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02960685
• Other study ID #: TELESONOEF2016
• Status: Recruiting
• Phase: N/A
• First received: November 5, 2016
• Last updated: November 9, 2016
• Start date: November 2016

Study information

• Verified date: November 2016
• Source: Hanyang University
• Contact: Changsun Kim, PhD
• Phone: 821050989479
• Email: flyes98[@]naver.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Background: Given that an experienced physician is not always available 24 hours a day, immediately and always available echocardiography is usually impossible in the emergency department (ED) and intensive care unit (ICU). To compensate this limitation, the investigators have investigated that offsite expert guided, inexperienced practitioner-performed ultrasonography could be effectively performed. In this study, the investigators aimed to investigate whether the offsite expert can effectively evaluate the visually estimated ejection fraction (EF) while watching and guiding the echocardiographic procedure of onsite novice examiner using the social network video calling chat.

Methods: sixty patients presenting to the ICU and requiring echocardiography will be included. Sixty novice practitioners without any previous experience of echocardiography will participate. Prior to their procedure, the onsite expert complete the echocardiography in advance and determine the EF using the modified Simpson's method (MSM, Reference value). Then, the novice physicians perform the echocardiography again with the offsite expert's guidance via video call. They obtain parasternal long and short axis view and EF is visually estimated to the nearest 5% (ex. 40%, 45% and etc) by the offsite expert while watching the ultrasound video on the smartphone display. The subjects requiring immediate management due to severe symptoms were excluded in this study. Interobserver variability between the calculated by onsite expert and visually estimated by offsite expert was assessed. The agreement of the visual estimated EF obtained by onsite expert and offsite expert via smartphone was evaluated by linear regression and Bland-Altman plots.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The patients admit to intensive care unit

Exclusion Criteria:

• Hemodynamic unstable patients

• Patients requiring immediate management

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

Procedure:
• Echocardiography

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 (4)

Choi 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. — View Citation

Kim C, Kang B, Choi HJ, Park JB. A Feasibility Study of Real-Time Remote CT Reading for Suspected Acute Appendicitis Using an iPhone. J Digit Imaging. 2015 Aug;28(4):399-406. doi: 10.1007/s10278-015-9775-7. — 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 — 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: 10.1186/1471-2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The non-inferiority test is conducted to analyze that the visually estimated ejection fraction via telesonography is not inferior to the quantitative ejection fraction by modified Simpson's method.		one day	No
Primary	Lineal regression is also conducted to show the correlation coefficient between visually estimated ejection fraction via telesonography and the quantitative ejection fraction by modified Simpson's method.		one day	No
Primary	The image quality assessment for transmitted image via commercially available video calling chat is conducted by using single stimulus method and double stimulus impairment scale		one day	No