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Clinical Trials/NCT02890797
NCT02890797
Terminated
Not Applicable

Evaluation of Thoracic Echography for Pleuroparenchymatous Anomaly Diagnosis Complicating Bronchiolitis: BronchioIUS

University Hospital, Toulouse1 site in 1 country19 target enrollmentJuly 12, 2018
ConditionsBronchiolitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchiolitis
Sponsor
University Hospital, Toulouse
Enrollment
19
Locations
1
Primary Endpoint
Presence of parenchymatous opacity
Status
Terminated
Last Updated
4 years ago

Overview

Brief Summary

The diagnosis of bronchiolitis, the most frequent lung infectious disease in infancy, is based on clinical examination. Chest X-ray is proposed when a lung parenchymal condensation is suspected. Chest ultrasound is supposed to be a useful tool in the diagnosis of these complication but is poorly evaluated. We aim to compare chest X-ray and chest ultrasound for the diagnosis of parenchymal condensation in infant with bronchiolitis.

Detailed Description

900 to 1000 children are admitted each year for bronchiolitis in the pediatric emergency department of the Toulouse Children Hospital. The diagnosis is based on clinical examination, but in some cases furthers examinations such as chest X-ray are necessary in order to look for a parenchymal condensation. Even if French recommendations do not place chest ultrasound in the care pathway to date, many recent studies show the usefulness, rapidity and reliability of ultrasound in parenchymal abnormalities. But regarding the bronchiolitis, few studies are available and including limited numbers of patients. In addition, the reduction of irradiation is a main goal, especially in children. We propose to performed a chest ultrasound in infants (\<24 months) admitted for bronchiolitis with an available chest X-ray, in order to compare the performance of both examinations (X-ray and ultrasound) for the diagnosis of parenchymal condensation. Besides, to correlate initial chest ultrasound results and clinical evolution, parents will be contacted by phone 1 month after inclusion. Primary outcome: The primary outcome is the sensitivity and specificity values of chest ultrasound for the diagnosis of parenchymal condensations diagnosed by chest X-ray. Positive and negative predictive values will also be estimated. This outcome is evaluated at the first visit (T0). Secondary outcomes: * To describe chest X-ray and ultrasound abnormalities in bronchiolitis. * To evaluate the performance of chest ultrasound to distinguish retractile and non-retractile opacities complicating bronchiolitis. * To study the correlation between clinical evolution at 1-month (malaise, place and duration of hospitalization, re-hospitalization, oxygen therapy, antibiotic therapy) and chest ultrasound results. Follow-up parameters are recorded during a telephone call 1 month after inclusion. Study design : It is a longitudinal, monocentric and prospective study with the aim to evaluate a diagnostic examination.

Registry
clinicaltrials.gov
Start Date
July 12, 2018
End Date
February 10, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Two years old patient at emergency Hospital (CHU-Toulouse) for bronchiolitis and performing of thoracic radiology
  • Informed consent formed to sign by family before the exam and the evidence of social security regime affiliation.

Exclusion Criteria

  • Patient with cardiopulmonary disease or underlying immunosuppression

Outcomes

Primary Outcomes

Presence of parenchymatous opacity

Time Frame: Inclusion

Presence of parenchymatous opacity during thoracic radiological exam

Secondary Outcomes

  • Parenchymatous retractable (or non retractable) opacity(Inclusion)
  • Radiological anomaly(Inclusion)

Study Sites (1)

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