Clinical trial NCT06382207: Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs
Official title: Effectiveness of the Eko Digital Stethoscope in Capturing Infant Electrocardiograms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tachyarrhythmia
Keywords: Infant Tachyarrhythmia
Cardiac Rhythm
Digital Stethoscope
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Eko Devices, Inc.
First posted: 2024-04-24
Enrollment: 100
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This proof-of-concept study will enroll infants, defined as individuals \<1 year of age. It will assess the feasibility and effectiveness of a physician and parent/caregiver in using the Eko DUO and CORE 500 to capture ECGs in patients \<10 kg in a clinic and home setting.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500
timeFrame: Baseline Visit
measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room using the CORE 500
timeFrame: Baseline Visit
measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician absent from the exam room, for CORE 500
timeFrame: Baseline Visit
measure: Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500 only
timeFrame: At end of study (two weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Christopher Snyder
role: PRINCIPAL_INVESTIGATOR
References: