Accuracy of ChARM automated respiratory rate counter in detecting fast breathing pneumonia in children

ISRCTN	ISRCTN14120515
DOI	https://doi.org/10.1186/ISRCTN14120515

Submission date: 16/09/2024
Registration date: 19/09/2024
Last edited: 19/09/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Background and study aims
According to the WHO Integrated Management of Childhood Illness (IMCI) guidelines, the diagnosis of pneumonia is primarily based on fast breathing. Identifying fast breathing is challenging, often leading to misdiagnosis of pneumonia and inappropriate treatment. Some improved pneumonia diagnostics (e.g., ChARM) can automatically count respiratory rate (RR) and identify fast breathing. This study aims to evaluate the performance of ChARM in counting RR in terms of accuracy and time to count RR.

Who can participate?
Children under 5 years of age presenting at the participating health facilities with suspected pneumonia (e.g., cough and/or difficulty breathing)

What does the study involve?
The children's RR will be measured using the ChARM device, and simultaneous chest movements will be video recorded. The video recordings were then sent to an expert panel for video RR interpretation. The accuracy of the ChARM device in counting RR will be assessed by comparing it to the expert panel's interpretation, which serves as the reference standard.

What are the possible benefits and risks of participating?
There were no direct benefits from participating in this study, but the results may help improve the diagnosis of pneumonia in children in the future. No risks were anticipated from participation in this study.

Where is the study run from?
The study is run by the Projahnmo Research Foundation, a non-governmental organization (NGO) based in Bangladesh.

When is the study starting and how long is it expected to run for?
July 2021 to April 2023

Who is funding the study?
The NIHR Global Health Research Unit on Respiratory Health (RESPIRE) at the University of Edinburgh funded the study

Who is the main contact?
Dr Ahad Mahmud Khan, Associate Scientist, Projahnmo Research Foundation, akhan@prfbd.org, ahad_mahmud@hotmail.com

Contact information

Dr Ahad Mahmud Khan
Public, Scientific, Principal Investigator

Projahnmo Research Foundation, Floor 7, House: 97A, Road: 25, Block # A, Banani
Dhaka
1213
Bangladesh

ORCID ID	0000-0002-4347-0825
Phone	+8801710574858
Email	akhan@prfbd.org

Dr Ahad Mahmud Khan
Public

Projahnmo Research Foundation, Floor 7, House: 97A, Road: 25, Block # A, Banani
Dhaka
1213
Bangladesh

Phone	+8801710574858
Email	ahad_mahmud@hotmail.com

Study information

Study design	Multicenter observational cross-sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	46078_PIS_v3.0_03nov2023.pdf
Scientific title	Accuracy of ChARM automated respiratory rate counter in detecting fast breathing pneumonia in children
Study acronym	CHARM-RR
Study hypothesis	The ChARM automated respiratory rate counter demonstrates comparable accuracy in detecting fast breathing pneumonia in children when compared to the reference standard of a video expert panel
Ethics approval(s)	1. Approved 18/07/2021, Bangladesh Medical Research Council (BMRC) (BMRC Bhaban, Mohakhali, Dhaka, 1212, Bangladesh; +8802-222298396; info@bmrcbd.org), ref: 39315022021 2. Approved 29/11/2021, Edinburgh Medical School Research Ethics Committee (EMREC) (The University of Edinburgh, College of Medicine and Veterinary Medicine, Teviot Place, Edinburgh, EH8 9AG, United Kingdom; +44 (0)131 650 1000; emrec@ed.ac.uk), ref: 21-EMREC-040
Condition	Diagnosis of fast breathing pneumonia in children
Intervention	Identification of fast-breathing pneumonia using the ChARM automated respiratory counter with a video expert panel as the reference standard. The children's respiratory rate will be measured using the ChARM device, and simultaneous chest movements will be video recorded. The duration of observation is approximately 30 minutes. This will be done once, with no follow-up. The video recordings will then be sent to an expert panel for interpretation of the respiratory rate.
Intervention type	Device
Pharmaceutical study type(s)	Not Applicable
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Children’s Automated Respiration Monitor (ChARM)
Primary outcome measure	The accuracy of ChARM in classifying fast breathing measured by comparing fast breathing detected by ChARM at enrollment with fast breathing assessed by the expert video panel.
Secondary outcome measures	The time taken by ChARM to count the respiratory rate was measured using a stopwatch or ARI timer at enrollment
Overall study start date	18/07/2021
Overall study end date	30/04/2023

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	0 Months
Upper age limit	59 Months
Sex	Both
Target number of participants	350
Total final enrolment	339
Participant inclusion criteria	1. Infants under two months presenting with any illness 2. Children aged 2-59 months presenting with cough and/or difficulty breathing
Participant exclusion criteria	1. Children presenting with any danger sign 2. Parents who refused to provide consent
Recruitment start date	06/12/2021
Recruitment end date	31/12/2022

Locations

Countries of recruitment

Bangladesh

Study participating centres

Institute of Child and Mother Health

Matuail
Dhaka
1362
Bangladesh

Zakiganj Upazila Health Complex

Zakiganj
Sylhet
3190
Bangladesh

Suprakandi Community Clinic

Zakiganj
Sylhet
3190
Bangladesh

Bhuyar Bazar Community Clinic

Zakiganj
Sylhet
3190
Bangladesh

Bakarshal Community Clinic

Zakiganj
Sylhet
3190
Bangladesh

Sponsor information

University of Edinburgh
University/education

Old College, South Bridge
Edinburgh
EH8 9YL
Scotland
United Kingdom

Phone	+44 (0)131 650 1000
Email	d.balharry@ed.ac.uk
Website	https://www.ed.ac.uk/
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Government

NIHR Global Health Research Unit on Respiratory Health (RESPIRE) at The University of Edinburgh

No information available

Results and Publications

Intention to publish date	01/10/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
Publication and dissemination plan	Dissemination will be through conference presentations and publications in peer-reviewed journals.
IPD sharing plan	The datasets generated during and/or analysed during the current study will be stored in the DataStore repository at the University of Edinburgh, UK (https://library.ed.ac.uk/research-support/research-data-service).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Thesis results		25/10/2023	17/09/2024	No	No
Participant information sheet	PIS and consent form version 3.0	03/11/2023	19/09/2024	No	Yes
Protocol article		15/11/2022	19/09/2024	Yes	No

Additional files

46078_PIS_v3.0_03nov2023.pdf: PIS and consent form

Editorial Notes

17/09/2024: Study's existence confirmed by the Bangladesh Medical Research Council (BMRC).