Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations

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. Identifier: NCT01138592
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : June 7, 2011
Information provided by:

Brief Summary:

Primary Objective: Evaluation of the utility of real-time, scope-to-scope communication between commercially-available 3M Littmann Electronic Model 3200 Electronic stethoscopes over a dedicated intranet system for the assessment of patients at remote (satellite) clinic locations by centrally-located (hub) medical providers.

Secondary Objective: Comparison of the accuracy of patient assessment between the remotely located, mid-level presenter with the centrally-located physician or nurse practitioner provider.

Condition or disease
Auscultation of Heart and Lungs

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study to Evaluate the Clinical Utility of 3M Littmann Scope-to-Scope Software for Real-time Assessment of Patients at Remote Clinic Locations by Centrally-located Medical Providers
Study Start Date : June 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Primary Care Patients
Any patient undergoing a telemedicine evaluation involving auscultation of the heart and lungs.

Primary Outcome Measures :
  1. Confirmation of hub (remote) observations with satellite (local) observations [ Time Frame: 30 minutes ]
    Presence or absence of heart or lung sound; e.g., murmurs, etc., and/or rales, rhonchii, wheezes.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Patients Hepatitis C Patients

Inclusion Criteria:

  1. Male and female subjects who are at least 18 years of age
  2. Subjects who are scheduled to undergo examination in a telemedicine setting
  3. Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form.

Exclusion Criteria:

  1. Subjects who are unwilling to undergo additional examination in a telemedicine setting,
  2. Any subject requiring time-critical medical intervention.
  3. Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.

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 identifier (NCT number): NCT01138592

United States, Arizona
North Country Health Care
Flagstaff, Arizona, United States, 86004
Sponsors and Collaborators
Principal Investigator: Eric Henley, MD, MPH North Country Health Care, Flagstaff, AZ

Responsible Party: Michael Walt, Clinical Research Specialist, 3M Infection Prevention Division Identifier: NCT01138592     History of Changes
Other Study ID Numbers: 05-003041
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: June 7, 2011
Last Verified: June 2011