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Auscultate Obese Patients Using Electronic and Traditional Stethoscopes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01665820
First Posted: August 15, 2012
Last Update Posted: June 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
3M
  Purpose
Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more effective in identifying referrable murmurs than using a traditional stethoscope.

Condition Intervention Phase
Chest Pathology Device: Auscultate with electronic or mechanical stethoscope (3M Littmann) Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by 3M:

Primary Outcome Measures:
  • Most severe cardiac lesion identified by auscultation & echocardiography [ Time Frame: 0-4 days ]

Secondary Outcome Measures:
  • Secondary cardiac lesion identified by auscultation & echocardiography [ Time Frame: 0 - 4 days ]
  • Other heart sounds identified by auscultation & echocardiography [ Time Frame: 0 - 4 days ]

Enrollment: 30
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665820


Locations
Lithuania
Lithuanian University of Health Sciences
Kaunas, Lithuania, LT-52490
Sponsors and Collaborators
3M
Investigators
Study Director: Egle Kalinauskiene, MD Lithuanian University of Health Sciences
  More Information

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01665820     History of Changes
Other Study ID Numbers: Study EM-05-012530
First Submitted: August 13, 2012
First Posted: August 15, 2012
Last Update Posted: June 7, 2013
Last Verified: June 2013

Keywords provided by 3M:
chest
pathology