Auscultate Obese Patients Using Electronic and Traditional Stethoscopes

Chest Pathology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665820
• Other study ID #: Study EM-05-012530
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2012
• Last updated: June 6, 2013
• Start date: October 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: 3M
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ministry of Health of the Republic of Lithuania: Lithuania
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chest Pathology

Intervention

Device:
• Auscultate with electronic or mechanical stethoscope (3M Littmann)

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
3M

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Most severe cardiac lesion identified by auscultation & echocardiography		0-4 days	No
Secondary	Secondary cardiac lesion identified by auscultation & echocardiography		0 - 4 days	No
Secondary	Other heart sounds identified by auscultation & echocardiography		0 - 4 days	No