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临床试验/NCT02890797
NCT02890797终止不适用

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

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年7月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
19
试验地点
2
主要终点
Presence of parenchymatous opacity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 2 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Patient with cardiopulmonary disease or underlying immunosuppression

研究组 & 干预措施

Bronchiolitis children

Other

Under two years old patient with bronchiolitis will have thoracic radiology

干预措施: radiology (Radiation)

结局指标

主要结局

Presence of parenchymatous opacity

时间窗: Inclusion

Presence of parenchymatous opacity during thoracic radiological exam

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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