Heart DiseasesSTELITNCT03344874
Comparison of Stethee® to the Conventional Stethoscope for Auscultation of Simulated Heart Sounds
A study testing Stethee® and 3MTM Littmann® Classic IIITM in people with Heart Diseases, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
Trial summary
The objective of this study is to compare the relative capability of Stethee® (new wireless digital stethoscope) and 3M™ Littmann® Classic III™ (conventional stethoscope) in the identification of manikin-simulated heart sounds by medical doctors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Stethee® and 3MTM Littmann® Classic IIITM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteMalaysia
- Study dates
- 26 Apr 2018to 1 Feb 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-specialist medical doctors with up to 6 years of working experience post-house officer training
- Non-specialist medical doctors currently working in the Medical, Paediatric, Anaesthesiology, and Emergency departments of specialist hospitals
Who cannot join
- 1. Non-specialist medical doctors who have worked in the Cardiology department for more than 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Stethee® to the Conventional Stethoscope for Auscultation of Simulated Heart Sounds: A Randomised, Crossover, Non-Inferiority Trial (STELIT)
The objective of this study is to compare the relative capability of Stethee® (new wireless digital stethoscope) and 3M™ Littmann® Classic III™ (conventional stethoscope) in the identification of manikin-simulated heart sounds by medical doctors. A randomised, non-blinded, two-period crossover, non-inferiority design will be used to compare the acoustic performance of the two stethoscopes. We aim to determine if Stethee® is as effective as 3M™ Littmann® Classic III™ for auscultation of simulated heart sounds, and whether Stethee® could be recommended for use in clinical practice based on a non-inferior comparison with 3M™ Littmann® Classic III™.
Read the detailed description
This is a randomised, non-blinded, two-period crossover, non-inferiority study. Stethee®, a new wireless digital stethoscope, is designed to minimise ambient noise associated with electronic stethoscopes. To date, its acoustic capability in comparison to the conventional stethoscope in the auscultation of heart sounds is not known. Therefore, it is important that Stethee®'s capability as a stethoscope with sound amplification be evaluated alongside the conventional stethoscope prior to its use in the clinical setting. As acoustic performance is the primary endpoint, a non-inferiority design is proposed to enable the comparison of the mutual functionalities of the two stethoscopes. The rationale for a non-inferiority design is that: (a) electronic stethoscopes have shown a marginal benefit over conventional stethoscopes in terms of acoustic performance; (b) electronic stethoscopes have several functional advantages over conventional stethoscopes: the ability to analyse heart sounds and record heart sounds, the availability of a database for storage of heart sounds for remote analysis; and (c) electronic stethoscopes were rated better than conventional stethoscopes in terms of the overall quality of auscultation.
The relative capability of Stethee® is compared to that of 3M™ Littmann® Classic III™ by the identification of heart sounds simulated by a manikin, which functions as a surrogate patient. A random sample of non-specialist doctors stratified by health centres in Perak, Malaysia, who meet eligibility criteria and provide written consent to participate, will be randomised to initial testing with Stethee® or 3M™ Littmann® Classic III™ to perform cardiac auscultation on a manikin and identify a set of 10 heart sounds. After a 10-minute break, they will repeat the auscultation of the same 10 simulated heart sounds but played in a different sequence with the alternate stethoscope. Following the completion of both tests, the doctors will be asked to complete a questionnaire that asks about their preference for either Stethee® or 3M™ Littmann® Classic III™ with respect to ease of use, audio clarity, and diagnostic accuracy. At the end of the study, answer sheets and preference questionnaires will be collected for grading and analysis.
- Conditions
- Heart Diseases
- Being tested
- Stethee®, 3MTM Littmann® Classic IIITM
- Keywords
- heart sounds, Stethee, electronic stethoscope
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stethee®Device
Stethee® is a new wireless digital stethoscope.
3MTM Littmann® Classic IIITMDevice
3MTM Littmann® Classic IIITM is the conventional stethoscope.
| Study group | Role | What they receive |
|---|---|---|
| Stethee (new stethoscope) | Experimental | Test 1: Use Stethee® to auscultate and identify a set of 10 manikin-simulated heart sounds.
Test 2: After a 10-minute break, use 3MTM Littmann® Classic IIITM to auscultate and identify the same set of 10 manikin-simulated heart sounds but played in a different sequence to Test 1. Receives: Device: Stethee®; Device: 3MTM Littmann® Classic IIITM |
| Littmann (conventional stethoscope) | Active comparator | Test 1: Use 3MTM Littmann® Classic IIITM to auscultate and identify a set of 10 manikin-simulated heart sounds.
Test 2: After a 10-minute break, use Stethee® to auscultate and identify the same set of 10 manikin-simulated heart sounds but played in a different sequence to Test 1. Receives: Device: Stethee®; Device: 3MTM Littmann® Classic IIITM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correctly identified manikin-simulated heart sounds
The proportion of correctly identified heart sounds between groups will be compared. The test consist of 10 cardiac conditions (represented by 10 manikin-simulated heart sounds). Subjects (medical doctors) are required to auscultate each heart sound and write the complete answer on the answer sheet. The 'all-or-nothing' marking scheme is used, i.e. answers must exactly match the marking scheme.
Measured: Measured immediately after the test
Secondary outcomes (3)
User preference for the two stethoscopes
User preference for the two stethoscopes with respect to ease of use, audio clarity, and diagnostic accuracy, will be compared between groups. This will be estimated as a proportion preferring Stethee® for each domain.
Measured: Measured immediately after the test
Difference in the performance between subgroup of doctors from different clinical settings
The performance of subgroup of doctors in specialist hospitals and doctors in non-specialist hospitals or primary care clinics will be compared. This will be estimated as a proportion difference of correctly identified heart sounds for each doctor subgroup.
Measured: Measured immediately after the test
Comparison of the performance of the two stethoscopes in identifying heart sounds of different levels of difficulty
The performance of the two stethoscopes in identifying heart sounds of different levels of difficulty (normal, easy, moderately difficult, difficult) will be compared. This is estimated as a proportion difference of correctly identified heart sounds for each type of heart sound.
Measured: Measured immediately after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start26 Apr 2018
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- M3DICINE Inc.
- Responsible party
- Principal investigator, Amanda Wei Yin Lim, Clinical Research Centre, Malaysia
- Investigators
- Amanda Wei Yin Lim, Pharmacy, Principal investigator, Clinical Research Centre, MalaysiaAmar Singh HSS, Paediatrics, Principal investigator, Clinical Research Centre, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344874
- Sponsor's protocol ID
- STELIT
- Acronym
- STELIT
- Status last verified
- Feb 2019
- First submitted
- 13 Nov 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Stethee® to the Conventional Stethoscope for Auscultation of Simulated Heart Sounds: A Randomised, Crossover, Non-Inferiority Trial (STELIT)
- ClinicalTrials.gov ID
- NCT03344874
- Acronym / sponsor ID
- STELIT / STELIT
- Conditions
- Heart Diseases
- Keywords
- heart sounds, Stethee, electronic stethoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- M3DICINE Inc.
- Study start
- 26 Apr 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
The objective of this study is to compare the relative capability of Stethee® (new wireless digital stethoscope) and 3M™ Littmann® Classic III™ (conventional stethoscope) in the identification of manikin-simulated heart sounds by medical doctors. A randomised, non-blinded, two-period crossover, non-inferiority design will be used to compare the acoustic performance of the two stethoscopes. We aim to determine if Stethee® is as effective as 3M™ Littmann® Classic III™ for auscultation of simulated heart sounds, and whether Stethee® could be recommended for use in clinical practice based on a non-inferior comparison with 3M™ Littmann® Classic III™.
Detailed description
This is a randomised, non-blinded, two-period crossover, non-inferiority study. Stethee®, a new wireless digital stethoscope, is designed to minimise ambient noise associated with electronic stethoscopes. To date, its acoustic capability in comparison to the conventional stethoscope in the auscultation of heart sounds is not known. Therefore, it is important that Stethee®'s capability as a stethoscope with sound amplification be evaluated alongside the conventional stethoscope prior to its use in the clinical setting. As acoustic performance is the primary endpoint, a non-inferiority design is proposed to enable the comparison of the mutual functionalities of the two stethoscopes. The rationale for a non-inferiority design is that: (a) electronic stethoscopes have shown a marginal benefit over conventional stethoscopes in terms of acoustic performance; (b) electronic stethoscopes have several functional advantages over conventional stethoscopes: the ability to analyse heart sounds and record heart sounds, the availability of a database for storage of heart sounds for remote analysis; and (c) electronic stethoscopes were rated better than conventional stethoscopes in terms of the overall quality of auscultation.
The relative capability of Stethee® is compared to that of 3M™ Littmann® Classic III™ by the identification of heart sounds simulated by a manikin, which functions as a surrogate patient. A random sample of non-specialist doctors stratified by health centres in Perak, Malaysia, who meet eligibility criteria and provide written consent to participate, will be randomised to initial testing with Stethee® or 3M™ Littmann® Classic III™ to perform cardiac auscultation on a manikin and identify a set of 10 heart sounds. After a 10-minute break, they will repeat the auscultation of the same 10 simulated heart sounds but played in a different sequence with the alternate stethoscope. Following the completion of both tests, the doctors will be asked to complete a questionnaire that asks about their preference for either Stethee® or 3M™ Littmann® Classic III™ with respect to ease of use, audio clarity, and diagnostic accuracy. At the end of the study, answer sheets and preference questionnaires will be collected for grading and analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stethee (new stethoscope) | Experimental | Device: Stethee®, Device: 3MTM Littmann® Classic IIITMTest 1: Use Stethee® to auscultate and identify a set of 10 manikin-simulated heart sounds. Test 2: After a 10-minute break, use 3MTM Littmann® Classic IIITM to auscultate and identify the same set of 10 manikin-simulated heart sounds but played in a different sequence to Test 1. |
| Littmann (conventional stethoscope) | Active comparator | Device: Stethee®, Device: 3MTM Littmann® Classic IIITMTest 1: Use 3MTM Littmann® Classic IIITM to auscultate and identify a set of 10 manikin-simulated heart sounds. Test 2: After a 10-minute break, use Stethee® to auscultate and identify the same set of 10 manikin-simulated heart sounds but played in a different sequence to Test 1. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Non-specialist medical doctors with up to 6 years of working experience post-house officer training
- Non-specialist medical doctors currently working in the Medical, Paediatric, Anaesthesiology, and Emergency departments of specialist hospitals
Key exclusion criteria (1 listed)
- 1. Non-specialist medical doctors who have worked in the Cardiology department for more than 6 months
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 |
|---|---|---|
| Stethee®Stethee® is a new wireless digital stethoscope. | Device | Littmann (conventional stethoscope), Stethee (new stethoscope) |
| 3MTM Littmann® Classic IIITM3MTM Littmann® Classic IIITM is the conventional stethoscope. | Device | Littmann (conventional stethoscope), Stethee (new stethoscope) |
Primary outcome
Correctly identified manikin-simulated heart sounds
Time frame: Measured immediately after the test
The proportion of correctly identified heart sounds between groups will be compared. The test consist of 10 cardiac conditions (represented by 10 manikin-simulated heart sounds). Subjects (medical doctors) are required to auscultate each heart sound and write the complete answer on the answer sheet. The 'all-or-nothing' marking scheme is used, i.e. answers must exactly match the marking scheme.
3 secondary outcomes
User preference for the two stethoscopes
Time frame: Measured immediately after the test
Difference in the performance between subgroup of doctors from different clinical settings
Time frame: Measured immediately after the test
Comparison of the performance of the two stethoscopes in identifying heart sounds of different levels of difficulty
Time frame: Measured immediately after the test
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 18 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Amanda Wei Yin Lim, Pharmacy principal investigator
Clinical Research Centre, Malaysia
Amar Singh HSS, Paediatrics principal investigator
Clinical Research Centre, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stethee® and 3MTM Littmann® Classic IIITM in people with Heart Diseases, run by Clinical Research Centre, Malaysia at 1 site in Malaysia.
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 2 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 18 Feb 2019. 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 Malaysia. 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?
Correctly identified manikin-simulated heart sounds (time frame: Measured immediately after the test). 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 18 Feb 2019.