Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382207
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-04-19
Brief Title:
Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Effectiveness of the Eko Digital Stethoscope in Capturing Infant Electrocardiograms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 childs 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 parentcaregiver at home for remote patient monitoring The CORE 500 may also have clinical utility in this patient population
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 parentcaregiver at home for remote patient monitoring The CORE 500 may also have clinical utility in this patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None