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Clinical Trials/NCT03280732
NCT03280732
Completed
Not Applicable

Lung Ultrasound in Diagnosing and Monitoring of Pulmonary Complications in Children With Acute Bronchiolitis

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 site in 1 country87 target enrollmentFebruary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchiolitis Acute
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Enrollment
87
Locations
1
Primary Endpoint
LUS vs CXR in diagnosing pulmonary complications in bronchiolitis
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Bronchiolitis is the leading cause of hospitalization in infants. The diagnosis is clinical and chest x-ray (CXR) should be reserved for severe cases in which signs of pulmonary complications are present. Nevertheless, CXR is performed in more than 50% of hospitalized patients with bronchiolitis, which exposes infants to ionizing radiation.

Data on the possible role of lung ultrasound (LUS) in children with bronchiolitis and suspected pulmonary complications have not been published yet.

The purpose of this study is to evaluate the use of LUS compared to CXR in diagnosing and monitoring pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis. The second purpose of the study is to evaluate the correlation between clinical course and ultrasound findings in children with bronchiolitis.

The inclusion of LUS in the diagnostic work-up of bronchiolitis could possibly reduce the misuse of CXR in infants and the exposure to ionizing radiations.

Detailed Description

Bronchiolitis is the most common lower respiratory tract infection that affects children younger than 24 months. The diagnosis is clinical and, according to international guidelines, chest x-ray (CXR) should be reserved for cases in which signs of pulmonary complications are present or where respiratory effort is severe to warrant intensive care unit admission. Despite these recommendations, CXR is still performed in about 50% of bronchiolitis (ranging from 24 to 77%), which exposes infants to ionizing radiation. Given its portability, no ionizing radiation, rapid and repeat testing, lung ultrasound (LUS) has become an emerging diagnostic tool for pneumonia, pleural effusion and pneumothorax in adults and children. At present, LUS is not included in the diagnostic work-up of bronchiolitis. Previous papers have reported that LUS may be useful in bronchiolitis because of a good correlation between clinical course and ultrasound findings. However, data on the possible role of LUS in children with bronchiolitis and suspected pulmonary complications have not been published yet. Enrolled patients will undergo a bedside LUS in the first 12 hours after CXR. LUS will be performed by one paediatrician with specific LUS expertise and blinded to clinical and radiological data. The paediatrician must have previously attended a specific course on LUS and supervised practical training. A Mindray-DC-T6 ultrasound machine equipped with a linear probe with frequencies ranging from 7.5 to 12 MHz will be use. LUS examination will consist of both longitudinal and transversal sections from the anterior, lateral and posterior chest wall according to the methodology described by Copetti et al. A radiologist will then independently repeat the LUS to test the sonographer inter-observer agreement. The radiologist will be blinded to the results of the previous studies (LUS and CXR). The LUS findings will be recorded on the data form together with patient demographics, symptoms, CXR findings and laboratory data. Patients with LUS positive for pulmonary complications will receive follow-up ultrasound every 48 hours until the resolution or the discharge.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
December 2018
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marcello Lanari

Director, Professor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Eligibility Criteria

Inclusion Criteria

  • Children hospitalized with a diagnosis of bronchiolitis
  • Age \< 24 months
  • CXR as part of usual clinical practice because of clinical suspicion of pulmonary complications
  • Informed written consent

Exclusion Criteria

  • chronic respiratory disease (i.e. bronchopulmonary dysplasia)
  • congenital heart disease
  • severe neuromuscular disease
  • congenital or acquired immunodeficiency

Outcomes

Primary Outcomes

LUS vs CXR in diagnosing pulmonary complications in bronchiolitis

Time Frame: 12 hours

To evaluate the use of LUS compared to CXR to diagnose pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis

Secondary Outcomes

  • Sonographer inter-observer agreement(12 hours)
  • LUS and severity of bronchiolitis(12 hours)

Study Sites (1)

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