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

Nagasaki University

Status: Not yet enrolling

Conditions: Bronchiolitis; Lower Respiratory Infection; LRTI; Pneumonia

Treatments: Diagnostic Test: Point-of-care lung ultrasound; Diagnostic Test: Chest X-ray (digital images)

Study type: Interventional

Funder types: Other

Identifiers

NCT05921526

ELUS study

Details and patient eligibility

About

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).

Full 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.

Enrollment: 616 estimated patients

Sex: All

Ages: 2 months to 16 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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616 participants in 2 patient groups

Intervention

Experimental group

Description:

Point-of-care lung ultrasound

Treatment:

Diagnostic Test: Point-of-care lung ultrasound

Control

Active Comparator group

Description:

Chest X-ray

Treatment:

Diagnostic Test: Chest X-ray (digital images)