Echo Acquisition Despite Geographic Separation by Replication of Human Movements (EAGER)

Baker Heart and Diabetes Institute

Status: Not yet enrolling

Conditions: Echocardiography

Treatments: Diagnostic Test: Standard echocardiogram; Diagnostic Test: Robot-guided echo

Study type: Interventional

Funder types: Other

Identifiers

NCT06742905

BakerHeartDiabetesI

Details and patient eligibility

About

Echocardiography is a cornerstone of modern cardiology management, but access in rural and remote areas is limited. We have developed a robot ("Edler" named after the originator of echocardiography) which enables a sonographer to complete an examination at a distance. This study seeks to compare the images obtained by both methods, the completeness of the exam over a feasible time, and to identify particular components of the exam that are difficult to obtain using the robot.

Full description

The EAGER study is an effectiveness and feasibility trial of robot -assisted echo.

Patients who have undergone a standard echo will be asked to have a repeat study with a different sonographer, working remotely, obtaining images using the robot. This study is limited to 1 hour and as many views as possible will be obtained. During the study, the remote sonographer and patient are in direct contact over a video link. Another person will be in the room with the patient and the patient will be instructed on the use of a stop switch which will disengage the robot if they feel uncomfortable.

The acquired images will be saved to the imaging cloud and interpreted by an imaging specialist blinded to the original echocardiogram. A side-by-side comparison will be undertaken for each view, and image quality and study completeness will be assessed.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having a conventional echocardiogram

Exclusion criteria

• Declined consent to undergo both examinations

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Standard echo

Active Comparator group

Description:

Standard echo exam provided by a sonographer using a standard view template

Treatment:

Diagnostic Test: Standard echocardiogram

Robotic echo

Experimental group

Description:

Robotic echo exam provided by a sonographer using a standard view template

Treatment:

Diagnostic Test: Robot-guided echo