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

Completed
Conditions
Auscultation of Heart and Lungs
Registration Number
NCT01138592
Lead Sponsor
Solventum US LLC
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Confirmation of hub (remote) observations with satellite (local) observations30 minutes

Presence or absence of heart or lung sound; e.g., murmurs, etc., and/or rales, rhonchii, wheezes.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

North Country Health Care

🇺🇸

Flagstaff, Arizona, United States

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