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Completed

NCT Number: NCT06839963

Kinshasa Lung Ultrasound Approach Validation

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

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Key information

Age range

3 month–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chittagong Medical College Hospital, Chittagong, Bangladesh

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About this study

Acute respiratory distress represents one of the main reasons for hospital admission in low and middle income countries. Prompt and accurate diagnosis of the underlying pathological process is crucial to guide appropriate management. Lung Ultrasound (LUS) is an innovative, non-invasive, low-cost, point-of-care tool with high diagnostic accuracy for acute pulmonary diseases. It is a superior alternative to chest radiography (CXR), which is costly and seldom available in low-resource hospitals. To date, we lack a validated LUS-enhanced paediatric diagnostic approach specifically designed for low-resource settings. The primary objective is to test whether a paediatric diagnostic algorithm integrating key elements of patient history, the presence of fever and a systematic bedside LUS examination, changes the admission diagnosis. We also seek to describe the frequency of predefined suspected diagnoses observed and semiquantify pulmonary aeration in children admitted with respiratory symptoms. We will perform a prospective, two-center observational study in the Democratic Republic of Congo (DRC) and Bangladesh in children aged 3 months to 14 years, admitted to hospital with acute respiratory symptoms and signs. The 'Kinshasa lung ultrasound' diagnostic approach (K-LUS) was developed by a group of paediatric clinical and imaging experts based on existing WHO clinical guidelines, published LUS evidence-based frameworks, primary LUS literature on single pathologies and existing paediatric point of care ultrasound guidelines. After the initial diagnosis is established by the treating physician, a research assistant will perform a LUS examination and apply the K-LUS approach, to observe whether there is a change in the initial diagnosis. This is a purely observational study and no intervention will be applied, neither will the patient treatment be changed in relation to the study. The integration of LUS in the diagnostic approach of the critically ill paediatric patient has the potential of improving outcomes and appropriateness of care. It could provide earlier and low-cost diagnosis in both district and referral hospitals, with a potential expansion to peripheral healthcare facilities and integration in existing integrated management of childhood illness (IMCI) guidelines. Such an approach would also help allocate scarce resources by limiting second line radiological imaging techniques only to patients in need.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged between 3 months and 14 years;
  • Admitted to the emergency department or ward with cough or difficulty in breathing;

Exclusion criteria

  • Expected short stay in the emergency department (< 6h)
  • Emergency transfer to other facilities
  • Refusal of informed consent by attending parent or caregiver, as appropriate
  • Lung ultrasound not feasible (e.g. non-availability of a trained physician)

Treatment and study plan

Primary outcomes

  1. The percentage of diagnostic changes

    Time frame: Immediately after the procedure (K-LUS diagnosis)

    The percentage of diagnostic changes prompted by the K-LUS approach compared with the initial clinical diagnosis given by the treating physician.

Secondary outcomes

  1. Percentage agreement for 10 prespecified WHO clinical diagnoses

    Time frame: Immediately after the procedure (K-LUS diagnosis)

    Percentage agreement for 10 prespecified WHO clinical diagnoses, namely (i) Asthma; (ii) Malaria; (iii) Anaemia/metabolic; (iv) Pneumothorax; (v) Congestive heart failure; (vi) Bronchiolitis; (vii) Pulmonary tuberculosis; (viii) Pneumonia; (ix) Pleural effusion (simple or empyema); (x) Haemothorax.

Other outcomes

  1. The net reclassification index

    Time frame: Immediately after the procedure (K-LUS diagnosis)

    The net reclassification index for parenchymal versus non-parencymal diagnosis prompted by the K-LUS protocol compared with the final diagnosis given by a panel after discharge.

  2. Lung ultrasound score

    Time frame: One time as early as possible after the initial clinical diagnosis (maximum 12 hours after the initial clinical diagnosis)

    An ultrasound clip from each individual zone will be saved to the machine for assessment and scoring and quality control purposes. All lung regions will be scored using the LUS aeration score(11,23).

    • 'A-pattern' defined as horizontal repetitions of the pleural line (A-lines) and scored as '0'.
    • 'B-patterns' scored as '1' when more than two well-spaced B-lines are present that cover less than 50% of the pleural line, or as '2' when B-lines cover more than 50% of the pleural line.
    • 'Consolidation-pattern' will be defined as an anatomical image of consolidation >1 cm in diameter and that will be scored as '3'.

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Validation of the Kinshasa Lung Ultrasound Approach for the Narrowing of Differential Diagnosis in Children Admitted With Acute Respiratory Symptoms in Low-resource Settings

Acronym: K-LUS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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