Effectiveness of Point-of-care Lung Ultrasound for the Management of Childhood Lower Respiratory Infections (ELUS)

November 8, 2023 updated by: Suraj BHATTARAI, Nagasaki University

Effectiveness of Point-of-care Lung Ultrasound vs Chest X-ray for the Management of Childhood Lower Respiratory Infections in Low-resource Setting: Single Center, Pragmatic, Open-label, Randomized, Controlled, Non-inferiority Clinical Trial

The goal of this clinical trial is to evaluate the effectiveness of point-of-care lung ultrasound versus chest X-ray for the management of childhood lower respiratory infections in a low-resource setting.

The main question it aims to answer is:

Is point-of-care lung ultrasound as effective as chest X-ray for the management of childhood LRIs in a low-resource setting?

Participants will be assigned to either a point-of-care lung ultrasound group (intervention) or a chest X-ray group (control), to compare the effect on overall case management and various clinical outcomes (time to symptom resolution, rate of antibiotic use, length of stay, treatment costs).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background:

Lower respiratory infections (LRIs) are the leading causes of mortality in children of low-middle income countries (LMICs) including Nepal; pneumonia being the major killer in under-5 population. Often, the cause of mortality is the delay in diagnosis and treatment, particularly when clinical assessments do not hint toward a diagnosis. In resource-limited settings, routine availability of chest X-ray (CXR) service is a challenge, it can be hazardous to children due to exposure to ionizing radiation. The Point-Of-Care Lung UltraSound (POCLUS) could be an alternative solution for the diagnosis and management of LRIs. Studies have already shown that lung ultrasound has a higher sensitivity and specificity than CXR in diagnosing childhood LRIs, however, none of the studies have yet evaluated its role in overall case management.

Methods:

Prospective, single-center, pragmatic, open-label, randomized, controlled, non-inferiority clinical trial, which will be conducted in the outpatient and emergency departments of a pediatric hospital in Nepal. A total of 616 children with clinical suspicion of LRI and requiring chest imaging will be randomized at 1:1 allocation to the intervention (POCLUS) and control (CXR) arms. Pediatricians will be trained to perform lung ultrasonography in children.

Outcomes:

Primary outcome is the proportion of 'correctly (effectively) managed' cases. Secondary outcomes include the proportion of cases with 'change in diagnosis and management plan due to intervention', time to symptom resolution, rate of antibiotic use, length of stay, and in-hospital costs, compared between intervention and control groups.

Study Type

Interventional

Enrollment (Estimated)

616

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Nepal
    • Bagmati
      • Bhaktapur, Bagmati, Nepal, 44800
        • Siddhi Memorial Hospital
        • Contact:
        • Sub-Investigator:
          • Dhruba Shrestha, MD

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

No

Description

Inclusion Criteria:

  • Children with a suspected lower respiratory infection (LRI) brought to the outpatient or emergency department,
  • Requiring chest image for evaluation at baseline.

Exclusion Criteria:

  • Children already hospitalized, received antibiotics, or had chest imaging at the hospital;
  • Follow-up (treated within the past 4 weeks) or referred cases;
  • Critical patients requiring emergency life-saving support including oxygen;
  • Children with one or more danger signs (lethargy or loss of consciousness, convulsion, unable to eat or vomiting everything, cyanosis, excess irritability)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Point-of-care lung ultrasound
Diagnostic test: Point-of-care lung ultrasound
Participants assigned to the intervention group will receive POCLUS which will be performed by one of the trained pediatricians. The procedure involves 12 views: two anterior views, two lateral views and two posterior views on both chest walls
Other Names:
  • POCLUS
Active Comparator: Control
Chest X-ray
Diagnostic test: Chest X-ray (digital images)
Participants assigned to the chest X--ray group will be sent to the Radiology department to get a CXR (digital) which will be performed by radio technicians like in routine care. Anteroposterior and/or posteroanterior chest images will be obtained. Reading/ reporting of the digital images will be done by both the radiologist and the enrolling pediatrician. The image/ clinical expert review panels (IERP/ CERP) will also have access to the images for review.
Other Names:
  • CXR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correct management plan at the baseline on the basis of clinical assessment and chest image findings
Time Frame: From the date of randomization until the final disposition of patient (i.e. discharge, refer), assessed up to 3 weeks. In case of non-hospitalized participants, outcomes evaluated during 2nd follow up (day 7-10 of enrollment), assessed up to 2 weeks.
Proportion of participants who are prescribed a correct management plan at the baseline on the basis of clinical assessment and chest image findings, either point-of-care lung ultrasound or chest X-ray
From the date of randomization until the final disposition of patient (i.e. discharge, refer), assessed up to 3 weeks. In case of non-hospitalized participants, outcomes evaluated during 2nd follow up (day 7-10 of enrollment), assessed up to 2 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diagnosis and management plan
Time Frame: From the date of randomization until Day3-5 of enrollment, assessed up to 1 week.
  • Diagnosis and Management Plan 1: Enrolling physician will fill a case report form with initial diagnosis and management plan (plan 1) based on the clinical assessment and LUS/CXR findings at baseline.
  • Decision regarding actual diagnosis and management plan (1a) is on treating physician's discretion.
  • Diagnosis and Management Plan 2: Enrolling physician will fill a second case report form (exactly same to the first one) on Day3-5 of enrollment with the diagnosis and management plan based on clinical assessment, chest image(s), and lab investigations.

This outcome is measured in hospitalized cases only.
From the date of randomization until Day3-5 of enrollment, assessed up to 1 week.
Time to symptom/sign resolution
Time Frame: From the date of randomization until disposition (i.e. discharge, referral) or symptom resolution criteria is met, whichever is earlier, assessed up to 3 weeks.
In hospitalized cases only
From the date of randomization until disposition (i.e. discharge, referral) or symptom resolution criteria is met, whichever is earlier, assessed up to 3 weeks.
Length of stay at hospital
Time Frame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
In hospitalized cases only
From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
Rate of antibiotic use
Time Frame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
In hospitalized cases only
From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
In-hospital treatment costs
Time Frame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
In hospitalized cases only
From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.

Collaborators and Investigators

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

Sponsor

Nagasaki University

Collaborators

London School of Hygiene and Tropical Medicine
Siddhi Memorial Foundation

Investigators

  • Principal Investigator: Suraj Bhattarai, MBBS, MSc, DTM&H, LSHTM/Nagasaki U/Siddhi Memorial Hospital
  • Principal Investigator: Bhim Dhoubhadel, MBBS MTM PhD DipPaed DTM&H, Nagasaki University
  • Principal Investigator: Shunmay Yeung, PhD MBBS FRCPCH MRCP DTM&H, LSHTM

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 18, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELUS study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol, deidentified participant data, and study tools may be shared with other researchers upon reasonable request, and decided by the investigators.

IPD Sharing Time Frame

Study protocol will be published in a journal. Clinical study report may be shared after the study is closed.

IPD Sharing Access Criteria

It will be decided by the team of principle investigators.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

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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