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Kinshasa Lung Ultrasound Approach Validation

NCT06839963 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 178

Last updated 2025-08-24

No results posted yet for this study

Summary

Study team will perform a prospective, observational study in two sites in the Democratic Republic of Congo (DRC) and Bangladesh in children aged 3 months to 14 years, admitted to hospital with acute respiratory symptoms. The Kinshasa lung ultrasound (K-LUS) approach integrates existing WHO clinical guidelines, lung ultrasound diagnostic accuracy evidence and paediatric ultrasound guidelines. The approach was built using a modified Delphi technique and integrates six LUS profiles, two clinical history features (timing of onset, trauma) and one clinical examination feature (fever) to suggest one among 10 clinical diagnosis. After the initial diagnosis is established by the treating physician, a research assistant will perform a LUS examination and apply the K-LUS approach. Comparison between the K-LUS derived diagnosis and the clinical diagnosis will be performed. After patient discharge a panel will also establish the most likely diagnosis according to all information available during patient stay.

This study is funded by the Wellcome Trust (ITPA grant) ref: WT-ITPA 2021/001

Conditions

  • Respiratory Disease
  • Children, Only

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Luigi Pisani · Mahidol Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Thailand

Eligibility

Min Age
3 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-05-16
Completion
2025-05-16

Countries

  • Bangladesh
  • Democratic Republic of the Congo
  • Sierra Leone

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 NCT06839963 on ClinicalTrials.gov