Clinical trial NCT03344874: Comparison of Stethee® to the Conventional Stethoscope for Auscultation of Simulated Heart Sounds
Official title: Comparison of Stethee® to the Conventional Stethoscope for Auscultation of Simulated Heart Sounds: A Randomised, Crossover, Non-Inferiority Trial (STELIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: heart sounds
Stethee
electronic stethoscope
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
Collaborators: name: M3DICINE Inc.
First posted: 2017-11-17
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Non-specialist medical doctors with up to 6 years of working experience post-house officer training
2. Non-specialist medical doctors currently working in the Medical, Paediatric, Anaesthesiology, and Emergency departments of specialist hospitals

Exclusion Criteria:

1. Non-specialist medical doctors who have worked in the Cardiology department for more than 6 months

Primary outcomes:
measure: Correctly identified manikin-simulated heart sounds
timeFrame: Measured immediately after the test
Secondary outcomes:
measure: User preference for the two stethoscopes
timeFrame: Measured immediately after the test
measure: Difference in the performance between subgroup of doctors from different clinical settings
timeFrame: Measured immediately after the test
measure: Comparison of the performance of the two stethoscopes in identifying heart sounds of different levels of difficulty
timeFrame: Measured immediately after the test
Other outcomes:
Locations:
city: Ipoh
country: Malaysia
facility: Raja Permaisuri Bainun Hospital
state: Perak
Study officials:
affiliation: Clinical Research Centre, Malaysia
name: Amanda Wei Yin Lim, Pharmacy
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Centre, Malaysia
name: Amar Singh HSS, Paediatrics
role: PRINCIPAL_INVESTIGATOR
References: