Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs
ConditionTachyarrhythmia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorVirginia Commonwealth University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age <1 year
No previous diagnosis of arrhythmia
Parent/caregiver can provide informed consent
Parent/caregiver can speak and understand simple English
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Eko Duo electronic stethoscope
DeviceA 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.
CORE 500 electronic stethoscope
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Digital Stethoscopes to measure neonatal tachyarrhythmiasOther 2 interventions
Trial outcomes
Primary outcomes
1
Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500
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.
Time frame
Baseline Visit2
Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician present in the exam room using the CORE 500
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.
Time frame
Baseline Visit3
Number and proportion of good-quality ECG recordings taken by parents/caregivers, with a physician absent from the exam room, for CORE 500
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.
Time frame
Baseline Visit4
Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500 only
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.
Time frame
At end of study (two weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
Eko Devices, Inc.
Collaborator
Source ClinicalTrials.gov