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

Tachyarrhythmia

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CORE 500 electronic stethoscope and a medical device called Eko Duo electronic stethoscope for people with tachyarrhythmia. The study is currently recruiting participants at 1 location. People eligible for this study include up to age 1 Year.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT06382207

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