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临床试验/NCT00808457
NCT00808457已完成不适用

Role of Chest Ultrasound in Diagnosing and Follow-up of Pneumonia. Prospective Comparison Between X-ray Chest Film in Two Planes and "Low-dose" Spiral Computed Tomography

University of Jena1 个研究点 分布在 1 个国家目标入组 397 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
397
试验地点
1
主要终点
sensitivity of chest ultrasound in diagnosing pneumonia

研究概览

简要总结

The study of a large number of patients (at least 200 patients) from several European centres aims to investigate the value of chest ultrasound in diagnosing and checking the course of pneumonia as compared to a chest X-ray film in two planes and - in case of a controversial X-ray finding- as compared to low-dose CT.

An X-ray finding is regarded controversial, if infiltrates cannot be reliably excluded or not reliably represented and if a definite diagnosis is, thus, not possible. A low-dose CT is indicated even in case of a positive chest ultrasound and negative X-ray finding. Sonographic recording and characterization of pneumonic infiltrates is performed both at the time of diagnosing and in the further course under therapy.

详细描述

The primary target criterion is

• Assessing the sensitivity of chest ultrasound in diagnosing pneumonia.

Secondary target criteria comprise

  • Assessing specificity, negative and positive predictive value of chest ultrasound at the time of diagnosing,
  • Characterizing pneumonic infiltrates at the time of diagnosing and further course,
  • Describing the association between clinical, X-ray and sonographic findings in the course of pneumonia.

The tertiary target criterion includes

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with clinically suspected CAP who received no antibiotic treatment yet
  • Patients in whom a chest X-ray in 2 planes was already performed, can be included in the study, if chest ultrasound is performed within 24 hours after X-ray and if the X-ray finding is neither available to nor known to the examiner doing the ultrasound examination.
  • Age > 18 years
  • Patient's declaration of consent is available.

排除标准

  • Patients with HAP
  • Age <18 years
  • Patients in whom the time difference between chest ultrasound and chest X-ray in 2 planes is more than 24 hours
  • Patients whose X-ray findings are with the examiner doing the ultrasound or are known to him
  • Pregnancy and lactation
  • Missing declaration of consent by the patient.

结局指标

主要结局

sensitivity of chest ultrasound in diagnosing pneumonia

时间窗: baseline diagnostic

次要结局

  • Specificity(baseline diagnostic)

研究者

发起方
University of Jena
申办方类型
Other

研究点 (1)

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