Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

Conditions

• Tachyarrhythmia

Eligibility Criteria

Sex

ALL

Age

N/A - 1 Year

Healthy Volunteers

Not accepted

Interventions

• Eko Duo electronic stethoscope — DEVICE
  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.
• CORE 500 electronic stethoscope — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Jan 17, 2025

Status verified

Mar 2026

Primary completion

Jul 31, 2026

Completion

Jul 31, 2026

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Other: Digital Stethoscopes to measure neonatal tachyarrhythmias
  Parental caregivers of infant research subjects are trained to use technology (digital stethoscopes) to decrease stress and unnecessary trips to the emergency room.

Primary Outcome Measure

Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500 [ Time Frame: Baseline Visit ]

Central Contacts

• Christopher Snyder
  8046284787
  [email protected]
• Margaret Lessard
  804-628-3093
  [email protected]

Locations (1)

Find similar trials in Richmond, VA

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