Clinical trial NCT03642730: Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging
Official title: Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Heart Failure
Cardiac Ischemia
Keywords: echocardiography
training
follow-up
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Echocardiography acquisition score [in %] [Operator's outcome]
timeFrame: Day 1
measure: Time to acquisition [in seconds] [Operator's performance]
timeFrame: Day 1
measure: Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]
timeFrame: Day 1
measure: Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]
timeFrame: Day 1
Secondary outcomes:
measure: Left ventricular Ejection Fraction [in %] [Measurement reproducibility]
timeFrame: Day 1
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Service de Cardiologie
Study officials:
affiliation: Hospital
name: Eric Saloux, MD
role: PRINCIPAL_INVESTIGATOR
References: