Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

Tachyarrhythmia Clinical Trial

Official title:

Effectiveness of the Eko Digital Stethoscope in Capturing Infant Electrocardiograms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382207
• Other study ID #: HM20029298
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: Christopher Snyder
• Phone: 8046284787
• Email: christopher.snyder[@]vcuhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Tachyarrhythmia
• Tachycardia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Eko Devices, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline Visit
Primary	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.	Baseline Visit
Primary	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.	Baseline Visit
Primary	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.	At end of study (two weeks)