Comparison of Stethee® to the Conventional Stethoscope for Auscultation of Simulated Heart Sounds (STELIT)

February 14, 2019 updated by: Amanda Wei Yin Lim, Clinical Research Centre, Malaysia

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™.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Raja Permaisuri Bainun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stethee (new stethoscope)

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.
Device: Stethee®
Stethee® is a new wireless digital stethoscope.
Device: 3MTM Littmann® Classic IIITM
3MTM Littmann® Classic IIITM is the conventional stethoscope.
Active Comparator: Littmann (conventional stethoscope)

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.
Device: Stethee®
Stethee® is a new wireless digital stethoscope.
Device: 3MTM Littmann® Classic IIITM
3MTM Littmann® Classic IIITM is the conventional stethoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured immediately after the test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User preference for the two stethoscopes
Time Frame: Measured immediately after the test
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 immediately after the test
Difference in the performance between subgroup of doctors from different clinical settings
Time Frame: Measured immediately after the test
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 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
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 immediately after the test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Research Centre, Malaysia

Collaborators

M3DICINE Inc.

Investigators

  • Principal Investigator: Amanda Wei Yin Lim, Pharmacy, Clinical Research Centre, Malaysia
  • Principal Investigator: Amar Singh HSS, Paediatrics, Clinical Research Centre, Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2018

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STELIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Diseases

Clinical Trials on Stethee®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe