Kinshasa Lung Ultrasound Approach Validation

NCT06839963 | Completed

• 1 other identifier: HCR24007
• Study Type: observational
• Target: 178
• Locations: 3 countries
• Sites: 3

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

Conditions

Respiratory Disease; Children, Only

Keywords

acute respiratory symptoms; children

Outcome Measures

Primary Outcomes (1)

• The percentage of diagnostic changes

  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 Outcomes (1)

• Percentage agreement for 10 prespecified WHO clinical diagnoses

  Immediately after the procedure (K-LUS diagnosis)

Other Outcomes (2)

• The net reclassification index

  Immediately after the procedure (K-LUS diagnosis)

• Lung ultrasound score

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

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (3)

Chittagong Medical College Hospital

Chittagong, 4203, Bangladesh

Location

Kinshasa School of Public Health, University of Kinshasa

Kinshasa, 11850, Democratic Republic of the Congo

Location

Pujehun Govt Hospital Medical

Pujehun, Sierra Leone

Location

Related Publications (25)

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• Pereda MA, Chavez MA, Hooper-Miele CC, Gilman RH, Steinhoff MC, Ellington LE, Gross M, Price C, Tielsch JM, Checkley W. Lung ultrasound for the diagnosis of pneumonia in children: a meta-analysis. Pediatrics. 2015 Apr;135(4):714-22. doi: 10.1542/peds.2014-2833. Epub 2015 Mar 16.

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• Ho MC, Ker CR, Hsu JH, Wu JR, Dai ZK, Chen IC. Usefulness of lung ultrasound in the diagnosis of community-acquired pneumonia in children. Pediatr Neonatol. 2015 Feb;56(1):40-5. doi: 10.1016/j.pedneo.2014.03.007. Epub 2014 Jul 15.

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• Riviello ED, Kiviri W, Twagirumugabe T, Mueller A, Banner-Goodspeed VM, Officer L, Novack V, Mutumwinka M, Talmor DS, Fowler RA. Hospital Incidence and Outcomes of the Acute Respiratory Distress Syndrome Using the Kigali Modification of the Berlin Definition. Am J Respir Crit Care Med. 2016 Jan 1;193(1):52-9. doi: 10.1164/rccm.201503-0584OC.

  PMID: 26352116 BACKGROUND

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• Reali F, Sferrazza Papa GF, Carlucci P, Fracasso P, Di Marco F, Mandelli M, Soldi S, Riva E, Centanni S. Can lung ultrasound replace chest radiography for the diagnosis of pneumonia in hospitalized children? Respiration. 2014;88(2):112-5. doi: 10.1159/000362692. Epub 2014 Jul 2.

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• Papanagnou D, Secko M, Gullett J, Stone M, Zehtabchi S. Clinician-Performed Bedside Ultrasound in Improving Diagnostic Accuracy in Patients Presenting to the ED with Acute Dyspnea. West J Emerg Med. 2017 Apr;18(3):382-389. doi: 10.5811/westjem.2017.1.31223. Epub 2017 Mar 3.

  PMID: 28435488 BACKGROUND

• Zanobetti M, Scorpiniti M, Gigli C, Nazerian P, Vanni S, Innocenti F, Stefanone VT, Savinelli C, Coppa A, Bigiarini S, Caldi F, Tassinari I, Conti A, Grifoni S, Pini R. Point-of-Care Ultrasonography for Evaluation of Acute Dyspnea in the ED. Chest. 2017 Jun;151(6):1295-1301. doi: 10.1016/j.chest.2017.02.003. Epub 2017 Feb 16.

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• Kruisselbrink R, Chan V, Cibinel GA, Abrahamson S, Goffi A. I-AIM (Indication, Acquisition, Interpretation, Medical Decision-making) Framework for Point of Care Lung Ultrasound. Anesthesiology. 2017 Sep;127(3):568-582. doi: 10.1097/ALN.0000000000001779. No abstract available.

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MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Luigi Pisani

  Mahidol Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Thailand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: February 21, 2025
• Study Start: January 1, 2025
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: August 24, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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

Locations

DE (1); SI (1); BA (1)