RecruitingNot ApplicableNCT06382207

Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

Effectiveness of the Eko Digital Stethoscope in Capturing Infant Electrocardiograms


Sponsor

Virginia Commonwealth University

Enrollment

100 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

When a newborn is diagnosed with tachyarrhythmia, they are generally started on medical therapies, most commonly a beta-blocker, while being observed in an inpatient setting. In most academic institutions, current practice is to provide parental teaching on use of a stethoscope to auscultate their child when there is suspicion for distress, in addition to requiring cardiopulmonary resuscitation (CPR) classes. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room.


Eligibility

Max Age: 1 Year

Inclusion Criteria4

  • Age <1 year
  • No previous diagnosis of arrhythmia
  • Parent/caregiver can provide informed consent
  • Parent/caregiver can speak and understand simple English

Exclusion Criteria4

  • Age ≥ 1 year
  • Patient has a pacemaker or implantable cardioverter defibrillator (ICD)
  • Parent/caregiver is unwilling or unable to provide informed consent
  • Parent/caregiver is unable to speak and understand English

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEEko Duo electronic stethoscope

A digital stethoscope with 1-lead electrocardiogram (ECG), the DUO, which pairs with a mobile application that allows the clinician to further engage with the device during and after a clinical visit. The application enables the clinician to visualize the sounds and electrical signals coming from the device in real time.

DEVICECORE 500 electronic stethoscope

The CORE 500 has 3 electrodes that produce a 3 lead ECG, which can be viewed through the Eko app. The CORE 500 also has a user interface screen which provides a number of functions including confirming when all three electrodes have good skin contact, showing a single lead ECG wave, providing heart rate, allowing the user to switch between audio modes, allowing the user to take recordings, and providing AI analysis results for recordings.


Locations(1)

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06382207