Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging (EPISODE)

This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Cardiac Disease; Cardiac Ischemia
• Intervention / Treatment: Device: TransThoracic Echocardiography imaging

Detailed Description

The primary objective of this study is to assess the feasibility for non-expert users (medical professionals but non-certified sonographers) to acquire parasternal, apical and subcostal views of suitable quality by using an existing ultrasound device (CE-marked, available in the market) and an additional guidance system (software prototype + probe motion tracking device). Such a system will help the user to place the probe on the patient and provide guidance for optimal acquisition of parasternal, apical and subcostal views.

The secondary objective of this study is to assess the feasibility for non-expert users to reproduce a simple clinical protocol by using an existing ultrasound device and the same additional guidance system.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CHU Caen Service de Cardiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All volunteers must have the ability to provide informed consent.
• All volunteers should be affiliated to the French Social Security.
• All volunteers will be scheduled for a routine transthoracic echocardiography exam in the echocardiography laboratory at the investigation site as part of standard care.

Exclusion Criteria:

• Subjects with congenital heart diseases (except bicuspid aortic valve)
• Pregnant women
• Adults lacking decisional capacity
• Adults placed under a legal protection regime (guardianship, curatorship, judicial protection)
• Adults not affiliated to the French Social Security
• Adults in emergent or critical condition
• Adults with active pain in the intended scanning region
• Adults with active skin disease or lesions in the intended scanning region
• Adults with allergy/sensitivity to ultrasound gel

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scanned patients; Scanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors	Device: TransThoracic Echocardiography imaging; ultrasound scanning
Experimental: Non-expert scanning volunteers; Non-expert scanning volunteers (among the medical staff at the clinical site) TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors	Device: TransThoracic Echocardiography imaging; ultrasound scanning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Echocardiography acquisition score [in %] [Operator's outcome]	Composite measurement that characterizes the echocardiography acquisition of the operator who is being assessed with respect to a 2D reference acquisition The echocardiography acquisition score is a combination of the view type score and the image quality score	Day 1
Time to acquisition [in seconds] [Operator's performance]	Time to acquisition [in seconds] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%	Day 1
Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]	Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the 2D reference acquisition [Reproducibility of the probe position and orientation]	Day 1
Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]	Displacement [in mm] of the echocardiography probe at the acquisition time with respect to the ideal (geometrical) acquisition estimated from 3D reference acquisition [Geometrical reliability of the probe position and orientation]	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular Ejection Fraction [in %] [Measurement reproducibility]	Left ventricular Ejection Fraction [in %] by Simpson's biplane method	Day 1

Collaborators and Investigators

• Sponsor: Philips Healthcare
• Investigators: Principal Investigator: Eric Saloux, MD, Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: echocardiography; follow-up; training
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: ICBE-2-11984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No