Kinshasa Lung Ultrasound Approach Validation (K-LUS)

August 22, 2025 updated by: University of Oxford

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 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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the procedure (K-LUS diagnosis)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the procedure (K-LUS diagnosis)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after the procedure (K-LUS diagnosis)
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'.
One time as early as possible after the initial clinical diagnosis (maximum 12 hours after the initial clinical diagnosis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Luigi Pisani, Mahidol Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

May 16, 2025

Study Completion (Actual)

May 16, 2025

Study Registration Dates

First Submitted

January 30, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

February 21, 2025

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCR24007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

With participant's consent, data from this study may be shared in a de-identified form with other groups or researchers in accordance with the MORU Data Sharing Policy (http://www.tropmedres.ac/data-sharing-policy).

IPD Sharing Access Criteria

Refer to MORU data sharing policy with other researchers to use in the future. https://www.tropmedres.ac/units/moru-bangkok/bioethics-engagement/data-sharing/moru-tropical-network-policy-on-sharing-data-and-other-outputs

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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