Clinical trial NCT04317521: : A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes in Pediatric Patients.
Official title: A Prospective Study Investigating the Use of the Eko CORE and Eko DUO Electronic Stethoscopes for Differentiation of Innocent vs. Pathologic Murmurs in Pediatric Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Murmurs
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 315
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children attending the Nemours Cardiac Center to include patients referred for a heart murmur who are aged from 0 to 17 years, patients with previously diagnosed heart conditions, patent ductus arteriosus (PDA) or valvular stenosis, who have not undergone corrective surgery and had a detectable murmur at their last visit. Patients who have an innocent or no detectable heart murmur will be from new referrals for a heart murmur, chest pain, syncope, or arrhythmia, or are currently outpatients in the cardiac clinic who had an innocent murmur or no detectable heart murmur in their previous (and current) clinic appointments, and meet the inclusion/exclusion criteria for the study.

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.

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

Primary outcomes:
measure: Comparison of stethoscope recordings between innocent, pathologic and none to determine if stethoscope can differentiate
timeFrame: Recording 2 minutes of heart sounds for each stethoscope
Secondary outcomes:
measure: Murmurs identified by stethoscope recording will be stratified based on age
timeFrame: 2 minutes of recording with two stethoscopes
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Alfred I duPont Hospital for Children
state: Delaware
Study officials:
affiliation: Nemours/Alfred I duPont Hospital for Children
name: Nicholas Slamon, MD
role: PRINCIPAL_INVESTIGATOR
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