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Improving Paediatric Pneumonia Diagnosis Using Digital Auscultation

NCT03959956 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 990

Last updated 2024-01-05

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Recording lung sound by a Smartscope

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

Sponsors & Collaborators

  • Projahnmo Research Foundation

    collaborator OTHER

  • University of Edinburgh

    lead OTHER

Eligibility

Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-12-26
Completion
2023-12-18

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03959956 on ClinicalTrials.gov