NCT03344874

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™.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

April 26, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

9 months

First QC Date

November 13, 2017

Last Update Submit

February 14, 2019

Conditions

Heart Diseases

Keywords

heart soundsStetheeelectronic stethoscope

Outcome Measures

Primary Outcomes (1)

  • 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 immediately after the test

Secondary Outcomes (3)

  • User preference for the two stethoscopes

    Measured immediately after the test

  • Difference in the performance between subgroup of doctors from different clinical settings

    Measured immediately after the test

  • Comparison of the performance of the two stethoscopes in identifying heart sounds of different levels of difficulty

    Measured immediately after the test

Study Arms (2)

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.

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.

Device: Stethee®Device: 3MTM Littmann® Classic IIITM

Interventions

Stethee®DEVICE

Stethee® is a new wireless digital stethoscope.

Littmann (conventional stethoscope)Stethee (new stethoscope)
3MTM Littmann® Classic IIITMDEVICE

3MTM Littmann® Classic IIITM is the conventional stethoscope.

Littmann (conventional stethoscope)Stethee (new stethoscope)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raja Permaisuri Bainun Hospital

Ipoh, Perak, 30450, Malaysia

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Amanda Wei Yin Lim, Pharmacy

    Clinical Research Centre, Malaysia

    PRINCIPAL INVESTIGATOR

  • Amar Singh HSS, Paediatrics

    Clinical Research Centre, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Pharmacist

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 17, 2017

Study Start

April 26, 2018

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)