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

Heart Failure Clinical Trial

— EPISODE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642730
• Other study ID #: ICBE-2-11984
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: January 1, 2021

Study information

• Verified date: February 2021
• Source: Philips Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Cardiac Ischemia
• Coronary Artery Disease
• Heart Diseases
• Heart Failure
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• TransThoracic Echocardiography imaging
ultrasound scanning

Locations

Country	Name	City	State
France	CHU Caen Service de Cardiologie	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Philips Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	Left ventricular Ejection Fraction [in %] [Measurement reproducibility]	Left ventricular Ejection Fraction [in %] by Simpson's biplane method	Day 1