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临床试验/NCT04012359
NCT04012359已完成不适用

Lung Ultrasound Characterization of Bullous Emphysema

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2019年6月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Prevalence of various ultrasound signs in the bullous emphysema group, according to a predetermined sonographic evaluation form, following a standardized segmentation of the chest

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) is a frequent disease affecting a growing number of adults in the world which is responsible for a large public health burden through heavy morbidity and mortality.

Emphysema is one of a wide spectrum of pulmonary complications linked to COPD, defined as the abnormal permanent enlargement of the airspaces distal to the terminal bronchioles accompanied by destruction of the alveolar wall. Disease progression is correlated to worsening and enlargement of emphysema lesions, sometimes conflating in sizeable bullae, deleterious to normal mechanical pulmonary function. Bullous emphysema (BE) is sometimes eligible to invasive curative treatment through surgery or interventional bronchoscopy.

Diagnosis of BE relies on computerized tomodensitometry (CT), the gold-standard for evaluating pulmonary parenchyma. However, CT is not always available, and bullous emphysema can present as pneumothorax on chest radiography.

The practice of lung ultrasound is currently growing in respiratory medicine and emergency departments owing to an increasing amount of evidence showcasing its reliability as a diagnostic tool, most notably for pneumothorax and other pleural diseases. Despite BE having been reported to present similarly to pneumothorax in ultrasound, its characteristics have not yet been precisely described.

The primary aim of this study is to describe BE using lung ultrasound. Participants with known BE on CT will undergo a simple ultrasound examination. The secondary aim is to compare the characteristics of BE to those of pneumothorax using lung ultrasound. To achieve this, a second group of participants with currently treated pneumothorax will also undergo lung ultrasound.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Bullous emphysema group
  • Consultation or scheduled hospitalization in a Pulmonary Medicine department
  • Past medical history of emphysema on computerized tomodensitometry dating less than two years
  • Bullous emphysema with subpleural contact of two or more intercostal spaces on tomodensitometry
  • Pneumothorax group
  • Hospitalized in a Pulmonary Medicine department for the treatment of a pneumothorax
  • Patent pneumothorax visible on chest x-ray dating less than 24 hours

排除标准

  • Bullous emphysema group
  • Current pneumothorax
  • Past medical history of pleurodesis or pleural thickening homolateral to the bullous emphysema
  • All patients
  • Organ failure (hemodynamic, neurological, respiratory)
  • Recent thoracic surgery dating less than 7 days with subcutaneous emphysema
  • Minor participant or otherwise deprived of their freedom or their ability to consent freely
  • No affiliation to social security

结局指标

主要结局

Prevalence of various ultrasound signs in the bullous emphysema group, according to a predetermined sonographic evaluation form, following a standardized segmentation of the chest

时间窗: 2 years

The following sonographic signs will be investigated : * Pleural sliding (presence/absence) * Z lines (presence/absence) * A line visibility increase (presence/absence) * B line (number per field) * pulmonary pulse (presence/absence) * lung-point (presence/absence) * intercostoaeric line thickness (in mm) For qualitative signs, the investigators will present proportions Quantitative signs will be reported using means, medians and standard-deviations

次要结局

  • Statistical comparison of ultrasound characteristics of bullous emphysema and pneumothorax(2 years)
  • Prevalence of various ultrasound signs in the pneumothorax group, according to a predetermined sonographic evaluation form, following a standardized segmentation of the chest(2 years)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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