The Accuracy of an Artificially-intelligent Stethoscope

NCT00564122 | Completed DMC

• 1 other identifier: 070904
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

This study will characterize the accuracy of a commercially available artificially-intelligent stethoscope in determining which childhood murmurs suggest underlying congenital structural heart disease and therefore warrant diagnostic echocardiograms.

Conditions

Heart Murmurs; Congenital Heart Disease; Structural Heart Disease

Keywords

Murmur; Artificial-Intelligence; Stethoscope; Congenital Heart Disease; Structural Heart Disease

Outcome Measures

Primary Outcomes (1)

• Sensitivity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease

  Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.

Secondary Outcomes (1)

• Specificity of the Artificially-Intelligent Stethoscope as compared with that of Pediatric Cardiologists in determining which patients needed echocardiograms because they have congenital structural heart disease.

  Not applicable; all data collection for any given patient will be completed within less than 12 hours--usually MUCH less than 12 hours.

Study Arms (1)

All subjects

Device: Artificially-Intelligent Stethoscope; Other: Physical Examination

Interventions

Artificially-Intelligent Stethoscope DEVICE

After subjects' medical visits are complete, the heart sounds of all subjects will be recorded and assessed by an artificially-intelligent stethoscope. Attempts will be made to make satisfactory 20-second recordings from a total of eight positions on the chest with the patient in supine and upright positions.

Also known as: Cardioscan, Zargis Medical Corporation, Serial Number 000127

All subjects

Physical Examination OTHER

A Pediatric Cardiologist will examine each subject to the extent needed to make clinical assessments. This represents the ordinary standard-of-care.

All subjects

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient must present to a consulted Cardiologist for a 1st non-primary care murmur evaluation. This will usually occur in an outpatient Pediatric Cardiology clinic site.

You may qualify if:

• The patient must present to a consulted cardiologist for a 1st non-primary care murmur evaluation.

You may not qualify if:

• Non English-speakers
• At least moderately agitated or disruptive patients
• An echocardiogram or a Cardiology evaluation was done previously
• The patient no longer has an ausculable murmur at presentation.
• The patient didn't have a transthoracic echocardiogram with Color Doppler done.
• Patients admitted to the NICU before protocol completes.
• Protocol can't be completed on the day of presentation.

Sponsors & Collaborators

• Akron Children's Hospital: lead
• Thomas C. Dispenza, M.D.: collaborator
• John R. Bockoven, M.D. M.B.A.: collaborator

Study Sites (3)

Akron Children's Hospital's Heart Center

Akron, Ohio, 44308, United States

Location

Akron Children's Hospital's Heart Center

Beachwood, Ohio, 44122, United States

Location

Akron Children's Hospital's Heart Center

Boardman, Ohio, 44512, United States

Location

MeSH Terms

Conditions

Heart Murmurs; Heart Defects, Congenital

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Thomas C. Dispenza, M.D.

  Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

• John R. Bockoven, M.D. M.B.A.

  Akron Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 23, 2007
• First Posted: November 27, 2007
• Study Start: December 1, 2007
• Study Completion: June 1, 2008
• Last Updated: November 1, 2011

Record last verified: 2011-10

Locations

US (3)