Improving Paediatric Pneumonia Diagnosis Using Digital Auscultation

NCT03959956 | Completed

• 1 other identifier: PR-19004
• Study Type: observational
• Target: 990
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate an automated interpretation algorithm of recorded lung sound by a digital stethoscope, name the Smartscope, among rural Bangladeshi children receiving community care in order to improve the diagnosis of childhood pneumonia at first level facility in low- and middle-income countries. A mixed-methods study will be conducted for a period of twelve months in rural Sylhet, Bangladesh. A total of 12 community health workers (CHWs) and 12 community healthcare providers (CHCPs) will be recruited and trained for this study. CHWs will conduct household surveillance to identify children with cough and difficult breathing and refer to nearby community clinic (CC). The CHCPs will screen the children at the CCs as per protocol and enroll the suspected cases with couth or difficult breathing. A total of 1003 children will be enrolled in this study. Enrolled children will be assessed for signs and symptoms of pneumonia including oxygen saturation. The children will have their lung sounds recorded by the Smartscope at four sequential locations. A listening panel comprises by pediatricians will generate one summary patient classification of normal, crackle, wheeze, crackle and wheeze, or uninterpretable. The Respiratory detector automated algorithm will be applied to the lung recording to generate an interpretation. The study hypothesis is more than 50% of patients will have quality lung sound recordings and the agreement between the automated computerized analysis by Respiratory Detector and an expert listening panel will be high (kappa \>0.5).

Conditions

Childhood Pneumonia

Keywords

Digital auscultation; Pneumonia; Lung sounds; IMCI; LMIC

Outcome Measures

Primary Outcomes (2)

• Quality of lung sound recording by healthcare worker

  Quality lung sound recordings using pre-determined quality metrics i.e., at least 75% interpretable lung sound segments per patient (3 out of 4 chest positions). and high between listener agreement for the presence or absence of abnormal lung sounds (kappa\>0.8).

  At the time of enrollment

• Performance of the automated analysis of lung sound

  It will be evaluated comparing with listener interpretation of classification of lung sound; assuming agreement will be high (kappa\>0.6)

  within 3 months after collection of recorded lung sound

Interventions

Recording lung sound by a Smartscope DIAGNOSTIC_TEST

Lung sound will be recorded from four chest points by an electronic stethoscope called Smartscope which can also classify the recorded lung sound.

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The study population will be children aged less than 60 months who will visit the community clinics of Zakiganj and Kanaighat Subdistrict of Sylhet, Bangladesh and identified as suffering from cough or difficult breathing.

You may qualify if:

• Age less than 60 months
• History or observation of cough or difficult breathing
• Provide written informed consent

You may not qualify if:

• If enrolled within the last 30 days in this study
• Severely ill children who need to be referred immediately
• Refusal to join the study

Sponsors & Collaborators

• University of Edinburgh: lead
• Projahnmo Research Foundation: collaborator

Study Sites (1)

Zakiganj Upazila Health Complex

Sylhet, Bangladesh

Location

Related Publications (10)

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  PMID: 27839855 BACKGROUND

• Walker CLF, Rudan I, Liu L, Nair H, Theodoratou E, Bhutta ZA, O'Brien KL, Campbell H, Black RE. Global burden of childhood pneumonia and diarrhoea. Lancet. 2013 Apr 20;381(9875):1405-1416. doi: 10.1016/S0140-6736(13)60222-6. Epub 2013 Apr 12.

  PMID: 23582727 BACKGROUND

• Rudan I, O'Brien KL, Nair H, Liu L, Theodoratou E, Qazi S, Luksic I, Fischer Walker CL, Black RE, Campbell H; Child Health Epidemiology Reference Group (CHERG). Epidemiology and etiology of childhood pneumonia in 2010: estimates of incidence, severe morbidity, mortality, underlying risk factors and causative pathogens for 192 countries. J Glob Health. 2013 Jun;3(1):010401. doi: 10.7189/jogh.03.010401.

  PMID: 23826505 BACKGROUND

• Margolis PA, Ferkol TW, Marsocci S, Super DM, Keyes LL, McNutt R, Harrell FE Jr. Accuracy of the clinical examination in detecting hypoxemia in infants with respiratory illness. J Pediatr. 1994 Apr;124(4):552-60. doi: 10.1016/s0022-3476(05)83133-6.

  PMID: 8151469 BACKGROUND

• Murphy RL, Vyshedskiy A, Power-Charnitsky VA, Bana DS, Marinelli PM, Wong-Tse A, Paciej R. Automated lung sound analysis in patients with pneumonia. Respir Care. 2004 Dec;49(12):1490-7.

  PMID: 15571639 BACKGROUND

• Grenier MC, Gagnon K, Genest J Jr, Durand J, Durand LG. Clinical comparison of acoustic and electronic stethoscopes and design of a new electronic stethoscope. Am J Cardiol. 1998 Mar 1;81(5):653-6. doi: 10.1016/s0002-9149(97)00977-6.

  PMID: 9514471 BACKGROUND

• Brooks D, Thomas J. Interrater reliability of auscultation of breath sounds among physical therapists. Phys Ther. 1995 Dec;75(12):1082-8. doi: 10.1093/ptj/75.12.1082.

  PMID: 7501711 BACKGROUND

• Gjlrup T, Bugge PM, Jensen AM. Interobserver variation in assessment of respiratory signs. Physicians' guesses as to interobserver variation. Acta Med Scand. 1984;216(1):61-6. doi: 10.1111/j.0954-6820.1984.tb03772.x.

  PMID: 6485882 BACKGROUND

• Emmanouilidou D, McCollum ED, Park DE, Elhilali M. Computerized Lung Sound Screening for Pediatric Auscultation in Noisy Field Environments. IEEE Trans Biomed Eng. 2018 Jul;65(7):1564-1574. doi: 10.1109/TBME.2017.2717280. Epub 2017 Jun 19.

  PMID: 28641244 BACKGROUND

• Ahmed S, Mitra DK, Nair H, Cunningham S, Khan AM, Islam AA, McLane IM, Chowdhury NH, Begum N, Shahidullah M, Islam MS, Norrie J, Campbell H, Sheikh A, Baqui AH, McCollum ED. Digital auscultation as a novel childhood pneumonia diagnostic tool for community clinics in Sylhet, Bangladesh: protocol for a cross-sectional study. BMJ Open. 2022 Feb 9;12(2):e059630. doi: 10.1136/bmjopen-2021-059630.

  PMID: 35140164 DERIVED

MeSH Terms

Conditions

Pneumonia; Respiratory Sounds

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: July 1, 2019
• Primary Completion: December 26, 2020
• Study Completion: December 18, 2023
• Last Updated: January 5, 2024

Record last verified: 2023-12

Locations

BA (1)