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

This study has been completed.
Sponsor:
Information provided by:
3M
ClinicalTrials.gov Identifier:
NCT01138592
First received: June 4, 2010
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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
Auscultation of Heart and Lungs

Study Type: Observational
Study Design: 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

Further study details as provided by 3M:

Primary Outcome Measures:
  • Confirmation of hub (remote) observations with satellite (local) observations [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Presence or absence of heart or lung sound; e.g., murmurs, etc., and/or rales, rhonchii, wheezes.


Estimated Enrollment: 150
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Primary Care Patients
Any patient undergoing a telemedicine evaluation involving auscultation of the heart and lungs.

  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

Primary Care Patients Hepatitis C Patients

Criteria

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.
  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: NCT01138592

Locations
United States, Arizona
North Country Health Care
Flagstaff, Arizona, United States, 86004
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Eric Henley, MD, MPH North Country Health Care, Flagstaff, AZ
  More Information

No publications provided

Responsible Party: Michael Walt, Clinical Research Specialist, 3M Infection Prevention Division
ClinicalTrials.gov Identifier: NCT01138592     History of Changes
Other Study ID Numbers: 05-003041
Study First Received: June 4, 2010
Last Updated: June 3, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 20, 2014