Telesonography for Visually Estimating Ejection Fraction

NCT02960685 | Unknown

• 1 other identifier: TELESONOEF2016
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure, Systolic

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

Echocardiography PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sixty patients who admit to intensive care unit Sixty novice sonographers without any previous experience of echocardiography Two offsite experts who are certified as trained echocardiologist by the Korean Society of Echocardiography One onsite expert who is board certified cardiologist

You may qualify if:

• The patients admit to intensive care unit

You may not qualify if:

• Hemodynamic unstable patients
• Patients requiring immediate management

Sponsors & Collaborators

• Hanyang University: lead

Study Sites (1)

Hanyang university guri hospital, Department of emergency medicine

Guri-si, GyeongGido, 471-701, South Korea

RECRUITING

Related Publications (5)

• 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. Epub 2011 Nov 8.

  PMID: 22067287 RESULT

• 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.

  PMID: 25700617 RESULT

• 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.

  PMID: 23249290 RESULT

• 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.

  PMID: 24138615 RESULT

• Kim C, Hur J, Kang BS, Choi HJ, Shin JH, Kim TH, Chung JH. Can an Offsite Expert Remotely Evaluate the Visual Estimation of Ejection Fraction via a Social Network Video Call? J Digit Imaging. 2017 Dec;30(6):718-725. doi: 10.1007/s10278-017-9974-5.

  PMID: 28484920 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Jeong-hun Shin, PhD

  Hanyang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changsun Kim, PhD

CONTACT

821050989479; flyes98@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 5, 2016
• First Posted: November 10, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2016
• Last Updated: November 10, 2016

Record last verified: 2016-11

Locations

KR (1)