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

Philips Healthcare55 enrolled

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Cardiac Disease Heart Failure Cardiac Ischemia

Interventions

TransThoracic Echocardiography imagingDEVICE

ultrasound scanning

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CHU Caen Service de Cardiologie

Caen, France

Outcomes

Primary Outcomes

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

Time frame: 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%

Time frame: 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 \[Reproducibility of the probe position and orientation\]

Time frame: 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 \[Geometrical reliability of the probe position and orientation\]

Time frame: Day 1

Secondary Outcomes

Left ventricular Ejection Fraction [in %] [Measurement reproducibility]

Left ventricular Ejection Fraction \[in %\] by Simpson's biplane method

Time frame: Day 1

Data from ClinicalTrials.gov

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