Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging

Not Applicable

Completed

• Conditions: Heart Failure; Cardiac Disease; Cardiac Ischemia
• Interventions: Device: TransThoracic Echocardiography imaging

• Registration Number: NCT03642730
• Lead Sponsor: Philips Healthcare

Brief Summary

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

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 Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scanned patients	TransThoracic Echocardiography imaging	Scanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors
Non-expert scanning volunteers	TransThoracic Echocardiography imaging	Non-expert scanning volunteers (among the medical staff at the clinical site) TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors

Primary Outcome Measures

Name	Time	Method
Echocardiography acquisition score [in %] [Operator's outcome]	Day 1	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
Time to acquisition [in seconds] [Operator's performance]	Day 1	Time to acquisition \[in seconds\] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%
Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]	Day 1	Displacement \[in mm\] of the echocardiography probe at the acquisition time with respect to the 2D reference acquisition \[Reproducibility of the probe position and orientation\]
Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]	Day 1	Displacement \[in mm\] of the echocardiography probe at the acquisition time with respect to the ideal (geometrical) acquisition estimated from 3D reference acquisition \[Geometrical reliability of the probe position and orientation\]

Secondary Outcome Measures

Name	Time	Method
Left ventricular Ejection Fraction [in %] [Measurement reproducibility]	Day 1	Left ventricular Ejection Fraction \[in %\] by Simpson's biplane method

Trial Locations

Locations (1)

CHU Caen Service de Cardiologie; 🇫🇷 Caen, France