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Improving Paediatric Pneumonia Diagnosis Using Digital Auscultation

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03959956
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : December 1, 2020
Projahnmo Research Foundation
Information provided by (Responsible Party):
University of Edinburgh

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).

Condition or disease Intervention/treatment
Childhood Pneumonia Diagnostic Test: Recording lung sound by a Smartscope

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Study Type : Observational
Estimated Enrollment : 1003 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Community Use of Digital Auscultation to Improve Diagnosis of Pediatric Pneumonia in Sylhet, Bangladesh
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. Quality of lung sound recording by healthcare worker [ Time Frame: At the time of enrollment ]
    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).

  2. Performance of the automated analysis of lung sound [ Time Frame: within 3 months after collection of recorded lung sound ]
    It will be evaluated comparing with listener interpretation of classification of lung sound; assuming agreement will be high (kappa>0.6)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03959956

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Contact: Salahuddin Ahmed, MBBS +880255035439 ext 102
Contact: Ashraful Islam, MBBS

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Zakiganj Upazila Health Complex Recruiting
Sylhet, Bangladesh
Contact: Arifa Islam, MBBS    +8801715777887   
Sponsors and Collaborators
University of Edinburgh
Projahnmo Research Foundation

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Edinburgh Identifier: NCT03959956    
Other Study ID Numbers: PR-19004
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
Digital auscultation
Lung sounds
Additional relevant MeSH terms:
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Respiratory Tract Infections
Lung Diseases
Respiratory Tract Diseases