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Auscultate Obese Patients Using Electronic and Traditional Stethoscopes

This study is not yet open for participant recruitment.
Verified August 2012 by 3M
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01665820
First received: August 13, 2012
Last updated: August 14, 2012
Last verified: August 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by 3M:

Primary Outcome Measures:
  • Most severe cardiac lesion identified by auscultation & echocardiography [ Time Frame: 0-4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary cardiac lesion identified by auscultation & echocardiography [ Time Frame: 0 - 4 days ] [ Designated as safety issue: No ]
  • Other heart sounds identified by auscultation & echocardiography [ Time Frame: 0 - 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2012
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665820

Contacts
Contact: Haroldas Razvadauskas, BSC +370-866375582 haroldraz@hotmail.com

Locations
Lithuania
Lithuanian University of Health Sciences Not yet recruiting
Kaunas, Lithuania, LT-52490
Principal Investigator: HAROLDAS Razvadauskas, Bsc            
Sponsors and Collaborators
3M
Investigators
Study Director: Egle Kalinauskiene, MD Lithuanian University of Health Sciences
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01665820     History of Changes
Other Study ID Numbers: Study EM-05-012530
Study First Received: August 13, 2012
Last Updated: August 14, 2012
Health Authority: Ministry of Health of the Republic of Lithuania: Lithuania

Keywords provided by 3M:
chest
pathology

ClinicalTrials.gov processed this record on May 19, 2013