Telesonography for Visually Estimating Ejection Fraction

NCT ID: NCT02960685

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure, Systolic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echocardiography

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* The patients admit to intensive care unit

Exclusion Criteria

* Hemodynamic unstable patients
* Patients requiring immediate management
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hanyang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Changsun Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeong-hun Shin, PhD

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hanyang university guri hospital, Department of emergency medicine

Guri-si, GyeongGido, South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Changsun Kim, PhD

Role: CONTACT

Phone: 821050989479

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kim

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 22067287 (View on PubMed)

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.

Reference Type RESULT
PMID: 25700617 (View on PubMed)

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.

Reference Type RESULT
PMID: 23249290 (View on PubMed)

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.

Reference Type RESULT
PMID: 24138615 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28484920 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TELESONOEF2016

Identifier Type: -

Identifier Source: org_study_id