Telesonography for Visually Estimating Ejection Fraction

• Conditions: Heart Failure, Systolic

• Registration Number: NCT02960685
• Lead Sponsor: Hanyang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Primary Completion: 2016-11
• Study First Submitted: 2016-11-05
• Study First Submitted QC: 2016-11-09
• Last Update Submitted: 2016-11-09
• Study First Posted: 2016-11-10
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• The patients admit to intensive care unit

Exclusion Criteria

• Hemodynamic unstable patients
• Patients requiring immediate management

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Hanyang university guri hospital, Department of emergency medicine; 🇰🇷 Guri, GyeongGido, Korea, Republic of