Auscultate Obese Patients Using Electronic and Traditional Stethoscopes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01665820
First received: August 13, 2012
Last updated: June 6, 2013
Last verified: June 2013
  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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: June 6, 2013
Health Authority: Ministry of Health of the Republic of Lithuania: Lithuania

Keywords provided by 3M:
chest
pathology

ClinicalTrials.gov processed this record on October 23, 2014