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

Echocardiographic Acquisition With Geographic Separation of Patients and Sonographers With Roboot Assistance (EAGER)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Echocardiography
• Intervention / Treatment: Diagnostic test: Standard echocardiogram; Diagnostic test: Robot-guided echo

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas H Marwick, MBBS, PhD, MPH; Phone Number: 0385321550; Email: tom.marwick@baker.edu.au

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Baker Heart and Diabetes Institute
      • Contact: Leah Wright, BSc, PhD; Phone Number: +61 3 8532 1550; Email: leah.wright@baker.edu.au
      • Contact: Elizabeth Dewar, BSc; Phone Number: +61 3 8532 1550; Email: liz.dewar@baker.edu.au
      • Principal Investigator: Thomas Marwick, MBBS, PhD, MPH
      • Sub-Investigator: Mats Isaksson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Having a conventional echocardiogram

Exclusion Criteria:

• Declined consent to undergo both examinations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard echo; Standard echo exam provided by a sonographer using a standard view template	Diagnostic test: Standard echocardiogram; Echocardiogram acquired by a sonographer at the patient's bedside
Experimental: Robotic echo; Robotic echo exam provided by a sonographer using a standard view template	Diagnostic test: Robot-guided echo; This echo will be performed by a remote sonographer, though a robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion complete	Proportion of a standard acquisition protocol obtainable using robotic acquisition over 1 hour	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion complete	Proportion of echo views with the same information provided by conventional echo	1 hour
Proportion diagnostic features correctly identified by robotic echo	Proportion diagnostic features correctly identified by robotic echo	1 hour

Collaborators and Investigators

• Sponsor: Baker Heart and Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Echocardiography
• Other Study ID Numbers: BakerHeartDiabetesI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data that underlie the results reported in this project (text, tables, figures and appendices) will be made available.
• IPD Sharing Time Frame: Dates - material will be made available immediately following publication, with no end date.

IPD Sharing Access Criteria

The authors are pleased to collaborate with other researchers who provide a methodologically sound proposal, to achieve the aims of the approved proposal, including individual participant data meta-analysis.

Proposals should be directed to tom.marwick@baker.edu.au. To gain access, data requestors will need to sign a data access agreement.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No