Auscultation of Heart and LungsNCT01138592
Pilot Study to Evaluate the Clinical Utility of Auscultation Software at Remote Locations
An observational study of Auscultation of Heart and Lungs, run by Solventum US LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Auscultation of Heart and Lungs
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Patients Hepatitis C Patients
Who may be able to join
- Male and female subjects who are at least 18 years of age
- Subjects who are scheduled to undergo examination in a telemedicine setting
- Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form.
Who cannot join
- Subjects who are unwilling to undergo additional examination in a telemedicine setting,
- Any subject requiring time-critical medical intervention.
- Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Auscultation of Heart and Lungs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Patients | Any patient undergoing a telemedicine evaluation involving auscultation of the heart and lungs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auscultation of Heart and LungsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Eric Henley, MD, MPH, Principal investigator, North Country Health Care, Flagstaff, AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138592
- Sponsor's protocol ID
- 05-003041
- Status last verified
- Sep 2024
- First submitted
- 4 Jun 2010
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01138592
- Acronym / sponsor ID
- 05-003041
- Conditions
- Auscultation of Heart and Lungs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Care Patients | – | –Any patient undergoing a telemedicine evaluation involving auscultation of the heart and lungs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Patients Hepatitis C Patients
Key inclusion criteria (3 listed)
- Male and female subjects who are at least 18 years of age
- Subjects who are scheduled to undergo examination in a telemedicine setting
- Subjects who are willing to voluntarily sign the compound Informed Consent and the Authorization to Disclose Protected Health Information Form.
Key exclusion criteria (3 listed)
- Subjects who are unwilling to undergo additional examination in a telemedicine setting,
- Any subject requiring time-critical medical intervention.
- Any subject who the investigator believes should not be included or is unsuitable for inclusion in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Related trials for Auscultation of Heart and Lungs
RecruitingObservational study
An Observational Study of Medical Device, HALD (Heart and Lung Diagnostic) to Obtain Heart and Lung Sound Recordings.
Auscultation of Heart and Lungs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Henley, MD, MPH principal investigator
North Country Health Care, Flagstaff, AZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auscultation of Heart and Lungs, run by Solventum US LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmation of hub (remote) observations with satellite (local) observations (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.