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

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

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.

Study Overview

• Status: Completed
• Conditions: Auscultation of Heart and Lungs

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Flagstaff, Arizona, United States, 86004
      • North Country Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary Care Patients Hepatitis C Patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Solventum US LLC
• Collaborators: 3M
• Investigators: Principal Investigator: Eric Henley, MD, MPH, North Country Health Care, Flagstaff, AZ

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: June 4, 2010
• First Submitted That Met QC Criteria: June 4, 2010
• First Posted (Estimated): June 7, 2010

Study Record Updates

• Last Update Posted (Actual): October 1, 2024
• Last Update Submitted That Met QC Criteria: September 27, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 05-003041