Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eko Duo electronic stethoscope, CORE 500 electronic stethoscope.
- Who it may be relevant to
- Registry conditions: Tachyarrhythmia. Basic parameters: up to 1 year · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of the Eko Digital Stethoscope in Capturing Infant Electrocardiograms
Overview
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.
Interventions
- Device Eko 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. - Device CORE 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.
Primary outcome measures
- Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500 [Time frame: Baseline Visit]
- Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room using the CORE 500 [Time frame: Baseline Visit]
- Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician absent from the exam room, for CORE 500 [Time frame: Baseline Visit]
- Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500 only [Time frame: At end of study (two weeks)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Virginia Commonwealth University — Richmond
Identifiers
NCT: NCT06382207 · HM20029298