Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs
Effectiveness of the Eko Digital Stethoscope in Capturing Infant Electrocardiograms
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500
Time Frame: Baseline Visit
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Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500.
A "good-quality" ECG recording is defined as one where the tracing is clear enough and with sufficient amplitude to define the p-wave, QRS complex, and t-wave, beyond a reasonable doubt, to allow determination of the patient's cardiac rhythm, by two independent pediatric electrophysiologists and a pediatric cardiologist.
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Baseline Visit
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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
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Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room, for CORE 500.
A "good-quality" ECG recording is defined as one where the tracing is clear enough and with sufficient amplitude to define the p-wave, QRS complex, and t-wave, beyond a reasonable doubt, to allow determination of the patient's cardiac rhythm, by two independent pediatric electrophysiologists and a pediatric cardiologist.
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Baseline Visit
|
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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, with a physician absent from the exam room, for CORE 500.
A "good-quality" ECG recording is defined as one where the tracing is clear enough and with sufficient amplitude to define the p-wave, QRS complex, and t-wave, beyond a reasonable doubt, to allow determination of the patient's cardiac rhythm, by two independent pediatric electrophysiologists and a pediatric cardiologist.
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Baseline Visit
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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)
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Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500.
A "good-quality" ECG recording is defined as one where the tracing is clear enough and with sufficient amplitude to define the p-wave, QRS complex, and t-wave, beyond a reasonable doubt, to allow determination of the patient's cardiac rhythm, by two independent pediatric electrophysiologists and a pediatric cardiologist.
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At end of study (two weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Snyder, Virginia Commonwealth University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM20029298
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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