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

Sponsor

Nemours Children's Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT04317521

Collaborator

(none)

315

Enrollment

Location

16.5

Actual Duration (Months)

19.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Murmurs	Device: Use of EKO Core and EKO Duo electronic stethoscopes

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.

Study Design

Study Type:

Observational

Actual Enrollment :

315 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

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.

Actual Study Start Date :

Oct 24, 2020

Actual Primary Completion Date :

Mar 11, 2022

Actual Study Completion Date :

Mar 11, 2022

Outcome Measures

Primary Outcome Measures

Comparison of stethoscope recordings between innocent, pathologic and none to determine if stethoscope can differentiate [Recording 2 minutes of heart sounds for each stethoscope]
The data science team will generate ROC curves for algorithm scores in the set of recorded heart sounds. Exploratory descriptive analyses of the algorithm will be performed by identifying clinical correlates to the characteristics most heavily weighted in detecting a pathologic murmur. The likelihood ratios of the test at sensitivity cut offs of 0.90, 0.95, 0.99 will also be determined. Patients will also be stratified based on age as a secondary outcome: For example, infants (0<1 years of age, since murmurs in this age group are more likely to be pathologic), young children (1-5 years of age), children (>5-12 years of age) and adolescents (>12 to<18 years of age). Murmurs will be classified as none, innocent [defined as no significant heart disease on echocardiogram and further classified as Still's, pulmonary flow murmur, systemic flow murmur, venous hums by the physician], or pathological by disease type (e.g., atrial septal defect (ASD), ventricular septal defect (VSD), etc.

Secondary Outcome Measures

Murmurs identified by stethoscope recording will be stratified based on age [2 minutes of recording with two stethoscopes]
Differentiated murmurs of infants between 0-1 years, young children, ages 1-5 years, children ages >5-12 years and adolescents >12 years < 18 years will be evaluated and murmurs identified

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Days to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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
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.
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:

Patients aged 18 and over
Patients and/or parents who are unable to read or speak English
Patients who have had corrective heart surgery for a heart defect
Auscultation cannot be performed properly at all locations
Patients not wishing to participate in study recordings

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nemours Alfred I duPont Hospital for Children	Wilmington	Delaware	United States	19803

Sponsors and Collaborators

Nemours Children's Clinic

Investigators

Principal Investigator: Nicholas Slamon, MD, Nemours/Alfred I duPont Hospital for Children

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

website for FDA approved devices

Publications

Responsible Party:

Nemours Children's Clinic

ClinicalTrials.gov Identifier:

NCT04317521

Other Study ID Numbers:

1575863-1

First Posted:

Mar 23, 2020

Last Update Posted:

Mar 15, 2022

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Heart Murmurs

Study Results

No Results Posted as of Mar 15, 2022