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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scanned patients | Experimental | Scanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors |
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| Non-expert scanning volunteers | Experimental | Non-expert scanning volunteers (among the medical staff at the clinical site) TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TransThoracic Echocardiography imaging | Device | ultrasound scanning |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular Ejection Fraction [in %] [Measurement reproducibility] | Left ventricular Ejection Fraction [in %] by Simpson's biplane method | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Saloux, MD | Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen Service de Cardiologie | Caen | 14033 | France |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D006333 | Heart Failure |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
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Masking is not applicable, since software study
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |