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

Philips

Status: Completed

Conditions: Cardiac Disease; Cardiac Ischemia; Heart Failure

Treatments: Device: TransThoracic Echocardiography imaging

Study type: Interventional

Funder types: Industry

Identifiers

NCT03642730

ICBE-2-11984

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Scanned patients

Experimental group

Description:

Scanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors

Treatment:

Device: TransThoracic Echocardiography imaging

Non-expert scanning volunteers

Experimental group

Description:

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

Treatment:

Device: TransThoracic Echocardiography imaging