<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01665820</url>
  </required_header>
  <id_info>
    <org_study_id>Study EM-05-012530</org_study_id>
    <nct_id>NCT01665820</nct_id>
  </id_info>
  <brief_title>Auscultate Obese Patients Using Electronic and Traditional Stethoscopes</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>3M</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more&#xD;
      effective in identifying referrable murmurs than using a traditional stethoscope.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study will enroll subjects who have greater than 30 BMI ratings. Each subject will receive 4&#xD;
      auscultation examinations. Two auscultations will be done by a cardiologist using both an&#xD;
      acoustic traditional stethoscope and an electronic stethoscope. Two additional auscultations&#xD;
      will be done by a 3rd year medical resident also using both an acoustic traditional&#xD;
      stethoscope and an electronic stethoscope. All determinations will be compared to&#xD;
      echocardiography results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Most severe cardiac lesion identified by auscultation &amp; echocardiography</measure>
    <time_frame>0-4 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary cardiac lesion identified by auscultation &amp; echocardiography</measure>
    <time_frame>0 - 4 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other heart sounds identified by auscultation &amp; echocardiography</measure>
    <time_frame>0 - 4 days</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Chest Pathology</condition>
  <arm_group>
    <arm_group_label>Auscultate with mechanical stethoscope</arm_group_label>
    <description>Cardiologist &amp; Medical Resident auscultate using mechanical stethoscope</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Auscultate with electronic stethoscope</arm_group_label>
    <description>Cardiologist &amp; Medical Resident auscultate using electronic stethoscope</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Auscultate with electronic or mechanical stethoscope (3M Littmann)</intervention_name>
    <arm_group_label>Auscultate with electronic stethoscope</arm_group_label>
    <arm_group_label>Auscultate with mechanical stethoscope</arm_group_label>
    <other_name>3M Littmann 3200 Electronic Stethoscope</other_name>
    <other_name>3M Littman Cardiology III Mechanical Stethoscope</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients greater or equal to 18 years of age, with a BMI greater than 30 and who have been&#xD;
        scheduled for an echocadiogram examination&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater or equal than 18 years of age&#xD;
&#xD;
          -  Referred for an echocardiogram&#xD;
&#xD;
          -  obese, as defined as having a BMI greater than 30&#xD;
&#xD;
          -  volunteers to participate in study&#xD;
&#xD;
          -  agrees to provide copy of echocardiogram exam report&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Investigator believes subject should not be included or is unsuitable for inclusion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Egle Kalinauskiene, MD</last_name>
    <role>Study Director</role>
    <affiliation>Lithuanian University of Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lithuanian University of Health Sciences</name>
      <address>
        <city>Kaunas</city>
        <zip>LT-52490</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lithuania</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>June 6, 2013</last_update_submitted>
  <last_update_submitted_qc>June 6, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>chest</keyword>
  <keyword>pathology</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01665820
org study id: Study EM-05-012530
nct id: NCT01665820
lead sponsor: 
has dmc: No
Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more
      effective in identifying referrable murmurs than using a traditional stethoscope.
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.
observational model: Cohort
time perspective: Prospective
measure: Most severe cardiac lesion identified by auscultation & echocardiography
time frame: 0-4 days
measure: Secondary cardiac lesion identified by auscultation & echocardiography
time frame: 0 - 4 days
measure: Other heart sounds identified by auscultation & echocardiography
time frame: 0 - 4 days
arm group label: Auscultate with mechanical stethoscope
description: Cardiologist & Medical Resident auscultate using mechanical stethoscope
arm group label: Auscultate with electronic stethoscope
description: Cardiologist & Medical Resident auscultate using electronic stethoscope
intervention type: Device
intervention name: Auscultate with electronic or mechanical stethoscope (3M Littmann)
arm group label: Auscultate with electronic stethoscope
arm group label: Auscultate with mechanical stethoscope
other name: 3M Littmann 3200 Electronic Stethoscope
other name: 3M Littman Cardiology III Mechanical Stethoscope
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Egle Kalinauskiene, MD
role: Study Director
affiliation: Lithuanian University of Health Sciences
facility: 
country: Lithuania
responsible party type: Sponsor