: A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes in Pediatric Patients.

NCT ID: NCT04317521

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 315 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-24
• Study Completion Date: 2022-03-11

Brief Summary

The Eko CORE and DUO stethoscopes are FDA approved electronic devices which have the capacity to record heart sounds. This study will utilize these devices to see if they can differentiate between pathologic and innocent heart murmurs in children.

Detailed Description

It is estimated that 50-70% of all children will have had a detectable heart murmur at some point in early life, but fortunately, the vast majority of these murmurs are benign asymptomatic "innocent" murmurs and not indicative of heart disease. However, there is concern about the ability of front-line pediatricians and family providers to distinguish between an innocent and pathological murmur. Thus, it is of no surprise that the largest number of new patient referrals to pediatric cardiologists is due to the detection of a murmur. Of those referred, 20-30% are typically diagnosed with trivial to significant heart disease based on auscultation and confirmatory echocardiography follow-up when necessary.

Having a child referred for a heart murmur evaluation causes significant anxiety for parents, even if the murmur is suggested to be innocent by the pediatrician and in some cases, clinical diagnostic testing is done unnecessarily. Interestingly, studies have shown that performing diagnostic electrocardiography, chest radiography, or echocardiography prior to clinical assessment by pediatric cardiologists did not offer additional assistance in differentiating murmurs. Unnecessary echocardiograms or other diagnostic tests for innocent murmur evaluation add unnecessary cost to the healthcare system.

Unfortunately, the unnecessary use of echocardiography for the diagnosis of innocent murmurs is also high among pediatric cardiologists. Thus, with the rising cost of health care, it is essential that we identify and target areas of practice that will enable us to increase efficiency and reduce unnecessary costs.

Specific characteristics of the sound of the murmur may help differentiate innocent from other murmurs, so improving auscultation skills and diagnosis based on auscultation and electrocardiography is very important in accurate diagnosis and reducing cost associated with the diagnosis of innocent and pathologic heart murmurs in children. The use of new technologies to improve auscultation and auscultation-based diagnosis could lead to improved diagnoses with decreased cost. New systems that used telemedicine techniques to transfer phonocardiogram (PCG) recordings to a cloud server have shown benefit in differentiating innocent versus pathologic murmurs, but cannot be used large scale, and are based on cardiology involvement.

The FDA-cleared Eko CORE device (Eko, Berkeley, California, USA) is a digital stethoscope that allows recording of the audio to produce a PCG. The FDA-cleared Eko DUO device is a digital stethoscope that allows recording of the audio to produce a PCG combined with a single lead electrocardiograph. The CORE and DUO both feature sound amplification and audio transmission to a smart phone, laptop or tablet via Bluetooth® that allows the user to open and playback sounds using an iOS, Android, or Microsoft Windows compatible application. The App provides the ability to save sounds within select Electronic Health Record (EHR) systems, share patient recordings with other practitioners, and annotate notes on recorded audio. Eko is intended for use on pediatric and adult patients. These features uniquely situate this device to accumulate large sets of auscultatory data on patients both with and without congenital heart disease (CHD).

In this study, we seek to use auscultatory audio recordings and phonocardiograms collected from pediatric patients using Eko CORE and DUO digital stethoscopes to develop a clinically significant algorithm that differentiates innocent from pathologic heart murmurs. As the Eko CORE and DUO devices are similar to a traditional stethoscope, an iconic tool widely accepted by patients and providers alike, its use to drive an automated detection algorithm is both feasible and attractive as a substitute for traditional auscultation. Furthermore, by providing an algorithmic analysis that can supplement clinical acumen, we hypothesize that we will improve overall diagnostic accuracy and show a decreased need for referral echocardiograms for innocent murmurs.

Conditions

Heart Murmurs

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Interventions

Use of EKO Core and EKO Duo electronic stethoscopes

Listen to heart murmurs

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients aged 0 to 17 years, who are able to read and speak English, and/or with parents or legal guardians who are able to read and speak English

2. New patients referred to the Nemours Cardiac Center for a heart murmur, chest pain, syncope, or arrhythmia. This could include children with suspected murmurs (but ultimately found to have no murmur by a cardiologist), innocent murmurs, and pathologic murmurs.

3. Patients with previously diagnosed heart condition, if they have not had any corrective surgeries and had a detectable murmur at their last clinic visit (for pathological and innocent murmurs) or had no detectable murmur at their last clinic visit (for no murmurs).

Exclusion Criteria

1. Patients aged 18 and over

2. Patients and/or parents who are unable to read or speak English

3. Patients who have had corrective heart surgery for a heart defect

4. Auscultation cannot be performed properly at all locations

5. Patients not wishing to participate in study recordings

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicholas Slamon, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours/Alfred I duPont Hospital for Children

Locations

Nemours Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Countries

United States

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Related Links

http://www.ekohealth.com

website for FDA approved devices

Other Identifiers

1575863-1

Identifier Type: -

Identifier Source: org_study_id