Severe Pneumonia Diagnostic in Pediatric Population by Lung Ultrasonography and Procalcitonin (PROLUSP)

Fundació Sant Joan de Déu

Status: Completed

Conditions: Pneumonia Childhood

Treatments: Diagnostic Test: Lung ultrasonography (LUS) or Chest X ray (CXR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04217980

FSJD-NEUMO-2017

Details and patient eligibility

About

Lung ultrasound (LUS) in combination with a biomarker has not yet been studied. The investigators propose a clinical trial where the primary aims are: 1. To assess whether an algorithm with LUS and procalcitonin (PCT) may be useful for diagnosing bacterial pneumonia; 2. To analyse the sensitivity and specificity of LUS vs chest radiograph (CXR).

Full description

Objectives: The general objective is to analyze whether a new algorithm approach of severe pneumonia in pediatric intensive unit (PICU) improves the quality of care. Objectives: 1- To analyze the sensitivity and specificity of lung ultrasound (LUS) compared respect to the chest radiography (CXR) in severe pneumonia and if LUS discriminates between bacterial and viral one. 2- If there is a lower CXR indication. 3- If is possible to reduce the dose of irradiation and costs associated with CXR. 4- To analyze the interobserver agreement of the LUS. 5- determine whether a diagnosis of pneumonia algorithm using LUS and procalcitonin may be useful in directing the indication of antibiotic therapy and / or the duration thereof.

Methodology: clinical, prospective, controlled, randomized, blinded intervention and 3-year trial. Inclusion of children under 18 years, with severe pneumonia, who enter (PICU). Experimental Group 1: pediatrician researcher (PR) will conduct a LUS at admission time, as a first test of lung image; in Group 2, CXR is conduced as first image. Patients will be classified into 3 subgroups, in both branches: a) if PCT is <1 ng /L and LUS is not suggestive of bacterial pneumonia, no antibiotic will be prescribed; b) if LUS is suggestive of bacterial pneumonia, regardless of the PCT, it will be recommended to start antibiotic therapy; c) If the ultrasound is suggestive of bacterial pneumonia but PCT is> 1 ng / L, antibiotic therapy will be recommended to cover other causes of infection. The same attitude will be performed, but depending on the CXR instead of the LUS, in group 2. Clinical variables, complementary tests and evolution data will be collected. Statistics by SPPS® 20.0. Informed consent will be requested and the study will be conducted according to the Helsinki Declaration guidelines and Good Clinical Practice.

Enrollment: 202 patients

Sex: All

Ages: 7 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children under 18
• severe pneumonia criteria
• admitted at PICU
• informed consent signed

Exclusion criteria

• previous respiratory disease (cystic fibrosis and/or immunosuppression)
• Nosocomial pneumonia development while in charge for community pneumonia.
• Researcher pediatrician has valuated the chest X ray before the PICU admission
• Included in other clinical trial

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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202 participants in 2 patient groups

Lung ultrasonography (LUS) group

Experimental group

Description:

Group 1: Lung ultrasonography is performed as the main (first) pulmonary image test

Treatment:

Diagnostic Test: Lung ultrasonography (LUS) or Chest X ray (CXR)

Chest X ray (CXR) group

Active Comparator group

Description:

Group 2: Chest X ray is performed as main (first) pulmonary image test

Treatment:

Diagnostic Test: Lung ultrasonography (LUS) or Chest X ray (CXR)