Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001046897
Ethics application status
Approved
Date submitted
7/05/2021
Date registered
9/08/2021
Date last updated
9/12/2021
Date data sharing statement initially provided
9/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Automatic detection of abnormal heart sounds in a paediatric cardiac population using a wireless electronic stethoscope
Scientific title
Automatic detection of abnormal heart sounds in a paediatric cardiac population using a wireless electronic stethoscope
Secondary ID [1] 304160 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood heart disease 321851 0
Condition category
Condition code
Cardiovascular 319577 319577 0 0
Other cardiovascular diseases
Cardiovascular 319578 319578 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In addition to the child have their heart sounds listened to using a standard stethoscope by a trained paediatric cardiologist, which is usual practice, children who enrol will also have their heart listened to using a digital stethoscope. They will have four recordings taken using the digital stethoscope, at four different locations on their chest. The recordings will take approximately 20 seconds at each location or approximately 2 minutes in total. We will also document important clinical details about the child such as their gender, age, height, weight, blood pressure, oxygen saturations, heart rate, reason for visit and diagnosis. We will also record the heart rhythm identified using the standard stethoscope. This information will be digitally sent to the study team in a deidentified format. Recordings will be completed by the study research assistant within the Cardiology Clinic at the Queensland Children's Hospital.
Intervention code [1] 320490 0
Diagnosis / Prognosis
Comparator / control treatment
Evaluation of underlying cardiac lesion in children aged 0-18 years against Echo Doppler as Gold Standard
Control group
Active

Outcomes
Primary outcome [1] 327437 0
Proportion of participants in which a diagnosis of ventricular septal defect can be made using the wireless electronic stethoscope
Timepoint [1] 327437 0
At the time of diagnosis of abnormal cardiac sounds
Primary outcome [2] 327918 0
Proportion of participants in which a diagnosis of patent ductus arteriosus can be made using the wireless electronic stethoscope
Timepoint [2] 327918 0
At the time of diagnosis of abnormal cardiac sounds
Primary outcome [3] 327919 0
Proportion of participants in which a diagnosis of innocent murmur can be made using the wireless electronic stethoscope
Timepoint [3] 327919 0
At the time of diagnosis of abnormal cardiac sounds
Secondary outcome [1] 397003 0
Proportion of participants in which a diagnosis of aortic stenosis can be made using the wireless electronic stethoscope
Timepoint [1] 397003 0
At the time of diagnosis of abnormal cardiac sounds
Secondary outcome [2] 397004 0
Proportion of participants in which a diagnosis of pulmonary stenosis can be made using the wireless electronic stethoscope
Timepoint [2] 397004 0
At the time of diagnosis of abnormal cardiac sounds
Secondary outcome [3] 397005 0
Proportion of participants in which a diagnosis of mitral regurgitation can be made using the wireless electronic stethoscope
Timepoint [3] 397005 0
At the time of diagnosis of abnormal cardiac sounds
Secondary outcome [4] 397006 0
Proportion of participants in which a diagnosis of atrial regurgitation can be made using the wireless electronic stethoscope
Timepoint [4] 397006 0
At the time of diagnosis of abnormal cardiac sounds
Secondary outcome [5] 397009 0
Proportion of participants in which a diagnosis of atrial septal defect can be made using the wireless electronic stethoscope
Timepoint [5] 397009 0
At the time of diagnosis of abnormal cardiac sounds

Eligibility
Key inclusion criteria
1) Males or females age 0 to 18 years who are with parents or legal guardians.
2) Normal, suspected AS, PS, VSD, PDA, innocent murmur, MR, AR, ASD and DCM.
3) For evaluation of heart sounds by stethoscope.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability or unwillingness of participant or legally acceptable representative to give written informed consent.
2) Patients aged 18 and over.
3) Auscultation cannot be performed properly at all locations.
4) Patients not wishing to participate in study recordings.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary objective is to train an algorithm for classification of abnormal heart sounds in paediatric cardiology. The primary endpoint will be an accurate system (with respect to sensitivity and specificity) for automatically classifying digitally-recorded heart sounds (captured using Stethee) according to the underlying cardiac lesion in children aged 0-18 years against assessment by a trained paediatric cardiology using a standard stethoscope.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2022
Actual
Date of last participant enrolment
Anticipated
29/07/2022
Actual
Date of last data collection
Anticipated
29/07/2022
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19342 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 33925 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 308532 0
Hospital
Name [1] 308532 0
Queensland Children's Hospital
Country [1] 308532 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
501 Stanley Street
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 309389 0
Commercial sector/Industry
Name [1] 309389 0
M3dicine
Address [1] 309389 0
88 Brandl St, Eight Mile Plains QLD 4113
Country [1] 309389 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308487 0
Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 308487 0
Level 7, Centre for Child Health Research
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 308487 0
Australia
Date submitted for ethics approval [1] 308487 0
24/03/2021
Approval date [1] 308487 0
21/04/2021
Ethics approval number [1] 308487 0
HREC/2021/QCHQ/65348

Summary
Brief summary
The primary objective of this study is to train an algorithm to accurately classify abnormal paediatric heart sounds using a digital stethoscope. Our hypothesis is that once trained, a digital stethoscope can identify abnormal paediatric heart sounds with similar accuracy to an experienced paediatric cardiologist using a standard stethoscope.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110870 0
A/Prof Benjamin Anderson
Address 110870 0
Level 7, Clinical Directorate
Queensland Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 110870 0
Australia
Phone 110870 0
+61 7 3068 5775
Fax 110870 0
Email 110870 0
[email protected]
Contact person for public queries
Name 110871 0
Mrs Jessica Suna
Address 110871 0
Level 4, Centre for Child Health Research
62 Graham Street
South Brisbane QLD 4101
Country 110871 0
Australia
Phone 110871 0
+61 7 30697256
Fax 110871 0
Email 110871 0
[email protected]
Contact person for scientific queries
Name 110872 0
Mrs Jessica Suna
Address 110872 0
Level 4, Centre for Child Health Research
62 Graham Street
South Brisbane QLD 4101
Country 110872 0
Australia
Phone 110872 0
+61 7 30697256
Fax 110872 0
Email 110872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.