Lower Respiratory InfectionELUSNCT05921526
Effectiveness of Point-of-care Lung Ultrasound for the Management of Childhood Lower Respiratory Infections
A study testing Point-of-care lung ultrasound and Chest X-ray (digital images) in people with Lower Respiratory Infection and LRTI, run by Nagasaki University at 1 site in Nepal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 months to 16 years
- Conditions the study is for
- Lower Respiratory Infection, LRTI, Pneumonia
- What is being tested?
- Point-of-care lung ultrasound and Chest X-ray (digital images)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 616 participants
- Where
- 1 siteNepal
- Study dates
- Jan 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a suspected lower respiratory infection (LRI) brought to the outpatient or emergency department,
- Requiring chest image for evaluation at baseline.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Siddhi Memorial Hospital
Bhaktapur, Bagmati, 44800
Rajbhandari, +977 01-6619382 ext. 00, adminofficer@smf.org.np
Dhruba Shrestha, MD
About this study
Official title: 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).
Read the 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.
- Conditions
- Lower Respiratory Infection, LRTI, Pneumonia, Bronchiolitis
- Being tested
- Point-of-care lung ultrasound, Chest X-ray (digital images)
- Keywords
- Point-Of-Care Lung UltraSound, POCLUS, Lung POCUS
- Medical subject headings
- Pneumonia, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care lung ultrasoundDiagnostic test
Also called POCLUS
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
Chest X-ray (digital images)Diagnostic test
Also called CXR
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Point-of-care lung ultrasound Receives: Diagnostic Test: Point-of-care lung ultrasound |
| Control | Active comparator | Chest X-ray Receives: Diagnostic Test: Chest X-ray (digital images) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct management plan at the baseline on the basis of clinical assessment and chest image findings
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
Measured: 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 outcomes (5)
Change in diagnosis and management plan
- 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.
Measured: From the date of randomization until Day3-5 of enrollment, assessed up to 1 week.
Time to symptom/sign resolution
In hospitalized cases only
Measured: 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
In hospitalized cases only
Measured: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
Rate of antibiotic use
In hospitalized cases only
Measured: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
In-hospital treatment costs
In hospitalized cases only
Measured: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study startJan 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagasaki University
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Siddhi Memorial Foundation
- Responsible party
- Principal investigator, Suraj BHATTARAI, London School of Hygiene and Tropical Medicine
- Investigators
- Suraj Bhattarai, MBBS, MSc, DTM&H, Principal investigator, LSHTM/Nagasaki U/Siddhi Memorial HospitalBhim Dhoubhadel, MBBS MTM PhD DipPaed DTM&H, Principal investigator, Nagasaki UniversityShunmay Yeung, PhD MBBS FRCPCH MRCP DTM&H, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921526
- Sponsor's protocol ID
- ELUS study
- Acronym
- ELUS
- Status last verified
- May 2023
- First submitted
- 18 May 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, deidentified participant data, and study tools may be shared with other researchers upon reasonable request, and decided by the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05921526
- Acronym / sponsor ID
- ELUS / ELUS study
- Conditions
- Lower Respiratory Infection, LRTI, Pneumonia, Bronchiolitis
- Keywords
- Point-Of-Care Lung UltraSound, POCLUS, Lung POCUS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 616 participants (estimated)
- Lead sponsor
- Nagasaki UniversityUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Siddhi Memorial Foundation
- Study start
- Jan 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Point-of-care lung ultrasoundPoint-of-care lung ultrasound |
| Control | Active comparator | Diagnostic Test: Chest X-ray (digital images)Chest X-ray |
Who may qualify
- Ages
- 2 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with a suspected lower respiratory infection (LRI) brought to the outpatient or emergency department,
- Requiring chest image for evaluation at baseline.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point-of-care lung ultrasoundAlso: POCLUSParticipants 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 | Diagnostic test | Intervention |
| Chest X-ray (digital images)Also: CXRParticipants 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. | Diagnostic test | Control |
Primary outcome
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
5 secondary outcomes
Change in diagnosis and management plan
Time frame: 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.
Length of stay at hospital
Time frame: 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-hospital treatment costs
Time frame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: Yes. Study protocol, deidentified participant data, and study tools may be shared with other researchers upon reasonable request, and decided by the investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suraj Bhattarai, MBBS, MSc, DTM&H principal investigator
LSHTM/Nagasaki U/Siddhi Memorial Hospital
Bhim Dhoubhadel, MBBS MTM PhD DipPaed DTM&H principal investigator
Nagasaki University
Shunmay Yeung, PhD MBBS FRCPCH MRCP DTM&H principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care lung ultrasound and Chest X-ray (digital images) in people with Lower Respiratory Infection and LRTI, run by Nagasaki University at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bhattarai (+977 9849158460 ext. 00, Suraj.Bhattarai@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.