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

NCT04317521 | Completed DMC

• 1 other identifier: 1575863-1
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Murmurs

Outcome Measures

Primary Outcomes (1)

• Comparison of stethoscope recordings between innocent, pathologic and none to determine if stethoscope can differentiate

  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.

  Recording 2 minutes of heart sounds for each stethoscope

Secondary Outcomes (1)

• Murmurs identified by stethoscope recording will be stratified based on age

  2 minutes of recording with two stethoscopes

Interventions

Use of EKO Core and EKO Duo electronic stethoscopes DEVICE

Listen to heart murmurs

Eligibility Criteria

• Age: 2 Days - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Nemours Children's Clinic: lead

Study Sites (1)

Nemours Alfred I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Related Publications (14)

• Rose-Felker K, Kelleman MS, Campbell RM, Oster ME, Sachdeva R. Appropriate Use and Clinical Impact of Echocardiographic "Evaluation of Murmur" in Pediatric Patients. Congenit Heart Dis. 2016 Dec;11(6):721-726. doi: 10.1111/chd.12379. Epub 2016 Jun 10.

  PMID: 27282847 BACKGROUND

• Sachdeva R, Allen J, Benavidez OJ, Campbell RM, Douglas PS, Eidem BW, Gold L, Kelleman MS, Lopez L, McCracken CE, Stern KW, Weiner RB, Welch E, Lai WW. Pediatric Appropriate Use Criteria Implementation Project: A Multicenter Outpatient Echocardiography Quality Initiative. J Am Coll Cardiol. 2015 Sep 8;66(10):1132-40. doi: 10.1016/j.jacc.2015.06.1327.

  PMID: 26337992 BACKGROUND

• Rose-Felker K, Kelleman MS, Campbell RM, Sachdeva R. Appropriateness of Outpatient Echocardiograms Ordered by Pediatric Cardiologists or Other Clinicians. J Pediatr. 2017 May;184:137-142. doi: 10.1016/j.jpeds.2017.01.073. Epub 2017 Feb 24.

  PMID: 28238480 BACKGROUND

• Kourtidou S, Evers PD, Jorgensen NW, Kronmal RA, Lewin MB, Schultz AH. Pediatric Appropriate Use Criteria for Outpatient Echocardiography: Practice Variations among Pediatric Cardiologists, Noncardiologist Subspecialists, and Primary Care Providers. J Am Soc Echocardiogr. 2017 Dec;30(12):1214-1224. doi: 10.1016/j.echo.2017.08.014. Epub 2017 Nov 1.

  PMID: 29079043 BACKGROUND

• Yi MS, Kimball TR, Tsevat J, Mrus JM, Kotagal UR. Evaluation of heart murmurs in children: cost-effectiveness and practical implications. J Pediatr. 2002 Oct;141(4):504-11. doi: 10.1067/mpd.2002.127502.

  PMID: 12378189 BACKGROUND

• Pyles L, Hemmati P, Pan J, Yu X, Liu K, Wang J, Tsakistos A, Zheleva B, Shao W, Ni Q. Initial Field Test of a Cloud-Based Cardiac Auscultation System to Determine Murmur Etiology in Rural China. Pediatr Cardiol. 2017 Apr;38(4):656-662. doi: 10.1007/s00246-016-1563-8. Epub 2017 Feb 2.

  PMID: 28150025 BACKGROUND

• Gardezi SKM, Myerson SG, Chambers J, Coffey S, d'Arcy J, Hobbs FDR, Holt J, Kennedy A, Loudon M, Prendergast A, Prothero A, Wilson J, Prendergast BD. Cardiac auscultation poorly predicts the presence of valvular heart disease in asymptomatic primary care patients. Heart. 2018 Nov;104(22):1832-1835. doi: 10.1136/heartjnl-2018-313082. Epub 2018 May 24.

  PMID: 29794244 BACKGROUND

• Chambers J, Kabir S, Cajeat E. Detection of heart disease by open access echocardiography: a retrospective analysis of general practice referrals. Br J Gen Pract. 2014 Feb;64(619):e105-11. doi: 10.3399/bjgp14X677167.

  PMID: 24567615 BACKGROUND

• Danford DA, Nasir A, Gumbiner C. Cost assessment of the evaluation of heart murmurs in children. Pediatrics. 1993 Feb;91(2):365-8.

  PMID: 8424012 BACKGROUND

• McCrindle BW, Shaffer KM, Kan JS, Zahka KG, Rowe SA, Kidd L. Cardinal clinical signs in the differentiation of heart murmurs in children. Arch Pediatr Adolesc Med. 1996 Feb;150(2):169-74. doi: 10.1001/archpedi.1996.02170270051007.

  PMID: 8556121 BACKGROUND

• Mackie AS, Jutras LC, Dancea AB, Rohlicek CV, Platt R, Beland MJ. Can cardiologists distinguish innocent from pathologic murmurs in neonates? J Pediatr. 2009 Jan;154(1):50-54.e1. doi: 10.1016/j.jpeds.2008.06.017. Epub 2008 Aug 9.

  PMID: 18692204 BACKGROUND

• Draper J, Subbiah S, Bailey R, Chambers JB. Murmur clinic: validation of a new model for detecting heart valve disease. Heart. 2019 Jan;105(1):56-59. doi: 10.1136/heartjnl-2018-313393. Epub 2018 Jul 26.

  PMID: 30049836 BACKGROUND

• Frias PA, Oster M, Daley PA, Boris JR. Outpatient echocardiography in the evaluation of innocent murmurs in children: utilisation benchmarking. Cardiol Young. 2016 Mar;26(3):499-505. doi: 10.1017/S1047951115000517. Epub 2015 Apr 23.

  PMID: 25902744 BACKGROUND

• Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.

  PMID: 24582925 BACKGROUND

Related Links

• website for FDA approved devices

MeSH Terms

Conditions

Heart Murmurs

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas Slamon, MD

  Nemours/Alfred I duPont Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 23, 2020
• Study Start: October 24, 2020
• Primary Completion: March 11, 2022
• Study Completion: March 11, 2022
• Last Updated: March 15, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)