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临床试验/NCT01572584
NCT01572584已完成不适用

Accuracy of Lung Ultrasound in the Prediction of Pneumothorax Volume Assessed by CT Scan

San Luigi Gonzaga Hospital1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2011年12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
115
试验地点
1
主要终点
The ultrasound lung point on the thorax wall versus the volume of pneumothorax at CT scan

研究概览

简要总结

Background

  • Assessment of the percentage of lung collapse is crucial in the therapeutic decision-making of pneumothorax.
  • The methods normally used to this purpose are radiological. Computerized tomography scan (CT) is highly accurate because it allows the exact evaluation of the volume of the air layer. However, in clinical practice assessment of the volume of pneumothorax mainly relies on the measurement of the inter-pleural distance at conventional chest radiography (CXR). This latter method is inaccurate.
  • Lung ultrasound is a new method highly accurate in the first diagnosis of pneumothorax, with a sensitivity superior to CXR and similar to CT in case of traumatic pneumothorax.
  • The scientific community is actually debating about the usefulness of lung ultrasound in the quantification of pneumothorax []. Lung ultrasound can assess the superficial extension of the pneumothorax, but cannot evaluate its volume.

Aim

  • Main purpose of the study is to compare measurement of the superficial extension of pneumothorax on the chest wall obtained by lung ultrasound, to the evaluation of the air volume performed by CT in patients with pneumothorax.
  • The main hypothesis of the study is that the cut-off between small (<11% of lung collapse) and large (>11% of lung collapse) pneumothorax can be identified by a lung ultrasound evaluation of the superficial extension of pneumothorax.
  • Second purpose of the study is to compare the accuracies of lung ultrasound and CXR in predicting the volume of pneumothorax assessed by CT.
  • Secondary hypothesis is that lung ultrasound demonstrates greater accuracy in the prediction of volume of pneumothorax and percentage of lung collapse.

Methods

  • Patients with a diagnosis of pneumothorax confirmed at CT are prospectively enrolled and submitted to lung ultrasound within 20 min from the CT study.
  • Different locations of the sonographic "lung point" on the chest wall (i.e. the point on the chest wall where the sonographic pattern of the normally aerated lung alternates with the pathologic sonographic pattern of pneumothorax) are compared with different volumes of pneumothorax measured by CT.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Radiologic diagnosis of pneumothorax
  • Clinical need to perform a CT scan
  • Ability to perform the lung ultrasound imaging within 20 minutes from the CT study

排除标准

  • age less than 16 years

结局指标

主要结局

The ultrasound lung point on the thorax wall versus the volume of pneumothorax at CT scan

时间窗: The ultrasound lung point that the best discriminates a pneumothorax volume more than 11%

次要结局

未报告次要终点

研究者

发起方
San Luigi Gonzaga Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Volpicelli

Medical Doctor, Department of Emergency Medicine

San Luigi Gonzaga Hospital

研究点 (1)

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