Auscultate Obese Patients Using Electronic and Traditional Stethoscopes

Study EM-05-012530 Benefit of Auscultation With 3M™ Littmann® 3200 Electronic Stethoscope to Diagnose Murmurs and Heart Pathologies in Overweight and Obese Patients With Increased Layers of Adipose Tissue

Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more effective in identifying referrable murmurs than using a traditional stethoscope.

Study Overview

• Status: Completed
• Conditions: Chest Pathology
• Intervention / Treatment: Device: Auscultate with electronic or mechanical stethoscope (3M Littmann)

Detailed Description

Study will enroll subjects who have greater than 30 BMI ratings. Each subject will receive 4 auscultation examinations. Two auscultations will be done by a cardiologist using both an acoustic traditional stethoscope and an electronic stethoscope. Two additional auscultations will be done by a 3rd year medical resident also using both an acoustic traditional stethoscope and an electronic stethoscope. All determinations will be compared to echocardiography results.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Lithuania
  • Kaunas, Lithuania, LT-52490
    • Lithuanian University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients greater or equal to 18 years of age, with a BMI greater than 30 and who have been scheduled for an echocadiogram examination

Description

Inclusion Criteria:

• Greater or equal than 18 years of age
• Referred for an echocardiogram
• obese, as defined as having a BMI greater than 30
• volunteers to participate in study
• agrees to provide copy of echocardiogram exam report

Exclusion Criteria:

-Investigator believes subject should not be included or is unsuitable for inclusion

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Auscultate with mechanical stethoscope; Cardiologist & Medical Resident auscultate using mechanical stethoscope	Device: Auscultate with electronic or mechanical stethoscope (3M Littmann); Other Names: 3M Littmann 3200 Electronic Stethoscope; 3M Littman Cardiology III Mechanical Stethoscope
Auscultate with electronic stethoscope; Cardiologist & Medical Resident auscultate using electronic stethoscope	Device: Auscultate with electronic or mechanical stethoscope (3M Littmann); Other Names: 3M Littmann 3200 Electronic Stethoscope; 3M Littman Cardiology III Mechanical Stethoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Most severe cardiac lesion identified by auscultation & echocardiography	0-4 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary cardiac lesion identified by auscultation & echocardiography	0 - 4 days
Other heart sounds identified by auscultation & echocardiography	0 - 4 days

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Study Director: Egle Kalinauskiene, MD, Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 13, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 15, 2012

Study Record Updates

• Last Update Posted (Estimate): June 7, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: chest; pathology
• Other Study ID Numbers: Study EM-05-012530