Chest PathologyNCT01665820
Auscultate Obese Patients Using Electronic and Traditional Stethoscopes
An observational study of Chest Pathology, run by Solventum US LLC at 1 site in Lithuania.
Trial summary
Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more effective in identifying referrable murmurs than using a traditional stethoscope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pathology
- What is being tested?
- Auscultate with electronic or mechanical stethoscope (3M Littmann)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteLithuania
- Study dates
- Oct 2012to Dec 2012
- 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: Patients greater or equal to 18 years of age, with a BMI greater than 30 and who have been scheduled for an echocadiogram examination
Who may be able to join
- Greater or equal than 18 years of age
- Referred for an echocardiogram
- obese, as defined as having a BMI greater than 30
- volunteers to participate in study
- agrees to provide copy of echocardiogram exam report
Who cannot join
- -Investigator believes subject should not be included or is unsuitable for inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study EM-05-012530 Benefit of Auscultation With 3M™ Littmann® 3200 Electronic Stethoscope to Diagnose Murmurs and Heart Pathologies in Overweight and Obese Patients With Increased Layers of Adipose Tissue
Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more effective in identifying referrable murmurs than using a traditional stethoscope.
Read the detailed description
Study will enroll subjects who have greater than 30 BMI ratings. Each subject will receive 4 auscultation examinations. Two auscultations will be done by a cardiologist using both an acoustic traditional stethoscope and an electronic stethoscope. Two additional auscultations will be done by a 3rd year medical resident also using both an acoustic traditional stethoscope and an electronic stethoscope. All determinations will be compared to echocardiography results.
- Conditions
- Chest Pathology
- Being tested
- Auscultate with electronic or mechanical stethoscope (3M Littmann)
- Keywords
- chest, pathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auscultate with electronic or mechanical stethoscope (3M Littmann)Device
Also called 3M Littmann 3200 Electronic Stethoscope, 3M Littman Cardiology III Mechanical Stethoscope
| Study group | Role | What they receive |
|---|---|---|
| Auscultate with mechanical stethoscope | Cardiologist \& Medical Resident auscultate using mechanical stethoscope Receives: Device: Auscultate with electronic or mechanical stethoscope (3M Littmann) | |
| Auscultate with electronic stethoscope | Cardiologist \& Medical Resident auscultate using electronic stethoscope Receives: Device: Auscultate with electronic or mechanical stethoscope (3M Littmann) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Most severe cardiac lesion identified by auscultation & echocardiography
Measured: 0-4 days
Secondary outcomes (2)
Secondary cardiac lesion identified by auscultation & echocardiography
Measured: 0 - 4 days
Other heart sounds identified by auscultation & echocardiography
Measured: 0 - 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PathologyStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Egle Kalinauskiene, MD, Study director, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01665820
- Sponsor's protocol ID
- Study EM-05-012530
- Status last verified
- Sep 2024
- First submitted
- 13 Aug 2012
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study EM-05-012530 Benefit of Auscultation With 3M™ Littmann® 3200 Electronic Stethoscope to Diagnose Murmurs and Heart Pathologies in Overweight and Obese Patients With Increased Layers of Adipose Tissue
- ClinicalTrials.gov ID
- NCT01665820
- Acronym / sponsor ID
- Study EM-05-012530
- Conditions
- Chest Pathology
- Keywords
- chest, pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 Aug 2012 (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.
Auscultating Obese patients using the 3M Littmann Electronic Model 3200 Stethoscope is more effective in identifying referrable murmurs than using a traditional stethoscope.
Detailed description
Study will enroll subjects who have greater than 30 BMI ratings. Each subject will receive 4 auscultation examinations. Two auscultations will be done by a cardiologist using both an acoustic traditional stethoscope and an electronic stethoscope. Two additional auscultations will be done by a 3rd year medical resident also using both an acoustic traditional stethoscope and an electronic stethoscope. All determinations will be compared to echocardiography results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auscultate with mechanical stethoscope | – | Device: Auscultate with electronic or mechanical stethoscope (3M Littmann)Cardiologist \& Medical Resident auscultate using mechanical stethoscope |
| Auscultate with electronic stethoscope | – | Device: Auscultate with electronic or mechanical stethoscope (3M Littmann)Cardiologist \& Medical Resident auscultate using electronic stethoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients greater or equal to 18 years of age, with a BMI greater than 30 and who have been scheduled for an echocadiogram examination
Key inclusion criteria (5 listed)
- Greater or equal than 18 years of age
- Referred for an echocardiogram
- obese, as defined as having a BMI greater than 30
- volunteers to participate in study
- agrees to provide copy of echocardiogram exam report
Key exclusion criteria (1 listed)
- -Investigator believes subject should not be included or is unsuitable for inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auscultate with electronic or mechanical stethoscope (3M Littmann)Also: 3M Littmann 3200 Electronic Stethoscope, 3M Littman Cardiology III Mechanical Stethoscope | Device | Auscultate with electronic stethoscope, Auscultate with mechanical stethoscope |
Primary outcome
Most severe cardiac lesion identified by auscultation & echocardiography
Time frame: 0-4 days
2 secondary outcomes
Secondary cardiac lesion identified by auscultation & echocardiography
Time frame: 0 - 4 days
Other heart sounds identified by auscultation & echocardiography
Time frame: 0 - 4 days
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 2 Oct 2024.
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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.
Egle Kalinauskiene, MD study director
Lithuanian University of Health Sciences
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 Chest Pathology, run by Solventum US LLC at 1 site in Lithuania.
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 5 inclusion and 1 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 2 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 Lithuania. 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?
Most severe cardiac lesion identified by auscultation & echocardiography (time frame: 0-4 days). 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 2 Oct 2024.