Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

Virginia Commonwealth University (VCU)

Status: Begins enrollment this month

Conditions: Tachyarrhythmia

Treatments: Device: Eko Duo electronic stethoscope; Device: CORE 500 electronic stethoscope

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06382207

HM20029298

Details and patient eligibility

About

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.

Full description

Tachyarrhythmias which would prompt an emergent call to the pediatric cardiologist following the child, along with simultaneous transportation towards the nearest, preferably pediatric, emergency room. In reality, parental caregivers may be blinded by their personal anxiety in caring for their child with a tachyarrhythmia, and their interpretation or ability to count their child's heart beats may not be accurate. This in turn, can result in unnecessary calls and visits to the emergency room which increase their utilization in addition to piling onto the already astounding cost of healthcare in the United States. Fortunately, newer technologies have emerged that allow for capture of cardiac rhythm that may provide a buffer between the infant and the emergency room. Eko manufactures 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.

Currently, the DUO is cleared for use on patients greater than or equal to 10 kg. This device may have additional clinical utility in pediatric patients <10 kg when used by either a physician or a parent/caregiver at home for remote patient monitoring. The CORE 500 may also have clinical utility in this patient population.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 1 year old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Digital Stethoscopes to measure neonatal tachyarrhythmias

Other group

Description:

Parental caregivers of infant research subjects are trained to use technology (digital stethoscopes) to decrease stress and unnecessary trips to the emergency room.

Treatment:

Device: CORE 500 electronic stethoscope

Device: Eko Duo electronic stethoscope