Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

Официальное название

Effectiveness of the Eko Digital Stethoscope in Capturing Infant Electrocardiograms

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Number and proportion of good-quality ECG recordings taken by physicians, for DUO and for CORE 500 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline Visit]
• Number and proportion of good-quality ECG recordings taken by parents/caregivers, at home, for CORE 500 only [Срок оценки: At end of study (two weeks)]

Критерии участия

Критерии включения

• Age <1 year
• No previous diagnosis of arrhythmia
• Parent/caregiver can provide informed consent
• Parent/caregiver can speak and understand simple English

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Virginia Commonwealth University — Richmond

Идентификаторы

NCT: NCT06382207 · HM20029298

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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