Clinical trial NCT06839963: Kinshasa Lung Ultrasound Approach Validation
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Respiratory Disease
Children, Only
Keywords: acute respiratory symptoms
children
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 178
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and children aged 3 months old to 14 years old presenting with cough or difficulty in breathing.

Brief 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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The percentage of diagnostic changes
timeFrame: Immediately after the procedure (K-LUS diagnosis)
Secondary outcomes:
measure: Percentage agreement for 10 prespecified WHO clinical diagnoses
timeFrame: Immediately after the procedure (K-LUS diagnosis)
Other outcomes:
measure: The net reclassification index
timeFrame: Immediately after the procedure (K-LUS diagnosis)
measure: Lung ultrasound score
timeFrame: One time as early as possible after the initial clinical diagnosis (maximum 12 hours after the initial clinical diagnosis)
Locations:
city: Chittagong
country: Bangladesh
facility: Chittagong Medical College Hospital
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health, University of Kinshasa
city: Pujehun
country: Sierra Leone
facility: Pujehun Govt Hospital Medical
Study officials:
affiliation: Mahidol Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Thailand
name: Luigi Pisani
role: PRINCIPAL_INVESTIGATOR
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