NCT06296693: POCUS-L

Diagnostic Accuracy of Pocket-size Lung Ultrasound in Pneumonia Etiology and Complications in Hospitalized Children

Status unknown NA Last updated 6 March 2024

What this trial tests

NA trial testing Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized in Pneumonia in 76 participants. Status unknown.

Timeline

1 April 2024

Primary endpoint
31 December 2024

30 April 2025

Quick facts

Lead sponsor	Centro Hospitalar Universitário de Santo António
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	76
Start date	1 April 2024
Primary completion	31 December 2024
Estimated completion	30 April 2025

Drugs / interventions tested

• Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized

Conditions studied

• Pneumonia — all drugs for Pneumonia →
• Pneumonia, Viral — all drugs for Pneumonia, Viral →
• Pneumonia, Bacterial — all drugs for Pneumonia, Bacterial →

Sponsor

Centro Hospitalar Universitário de Santo António

Who can join

Adults 12 Months to 18, any sex, with Pneumonia or Pneumonia, Viral. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

1. Background and study aims Pneumonia is the leading infectious cause of death in children worldwide. Although the diagnosis is clinical, a chest radiograph (CXR) is often necessary to clarify it, exposing the patient to radiation. Ultrasound has been increasingly used in the evaluation of the lung parenchyma without exposing patients to radiation. The pocket-size Point-of-Care Ultrasound (POCUS) can be used at the patient's bedside proving comfort and saving time. Evidence suggests that ultrasound can detect CAP (community-acquired pneumonia) in children with similar accuracy and reliability as CXR. However, few studies evaluated the ability to distinguish the aetiology of pneumonia and none used a pocket-size POCUS device. This study aims to assess, for the first time, the diagnostic accuracy of a pocket-size POCUS device for the etiological diagnosis of CAP vs. CXR, in paediatric ages. Secondarily, the investigators intend to evaluate the correlation between CXR image vs. ultrasound, the correlation between clinical progression and ultrasound images, and the diagnostic accuracy to detect complications.
2. Who can participate:

The investigators will include, consecutively, all children aged \>12 months and \<18 years hospitalized to the Paediatric Department with the diagnosis of CAP on admission. The investigators will exclude children hospitalized with nosocomial pneumonia, with cystic fibrosis diagnosis or on long-term domiciliary ventilation.
3. What does the study involve:

The diagnostic accuracy between POCUS and CXR in differentiating the type of pneumonia will be assessed. All participants will perform a POCUS at admission, daily during hospitalization, 15 days and 1 month after discharge. All children will also undergo a CXR upon admission and whenever necessary.
4. What are the possible benefits and risks of participating:

Children will have a more frequent and serial assessment of CAP, which does not involve risks.
5. Where is the study run from:

The study if from Centro Materno Infantil do Norte - Centro Hospitalar Universitário de Santo António, a tertiary paediatric referral centre.
6. When is the study starting and how long is it expected to run for:

The recruitment period is expected to start in January/2024 and end in January 2025.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.