Clinical trial NCT04012359: Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax
Official title: Lung Ultrasound Characterization of Bullous Emphysema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Emphysema
Keywords: Lung ultrasound
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from multiple Pulmonary Departments in France, in the setting of University Hospitals. All participants fulfilling inclusion criteria will be included.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prevalence of various ultrasound signs in the bullous emphysema group, according to a predetermined sonographic evaluation form, following a standardized segmentation of the chest
timeFrame: 2 years
Secondary outcomes:
measure: Prevalence of various ultrasound signs in the pneumothorax group, according to a predetermined sonographic evaluation form, following a standardized segmentation of the chest
timeFrame: 2 years
measure: Statistical comparison of ultrasound characteristics of bullous emphysema and pneumothorax
timeFrame: 2 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: Pulmonary Medicine, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital
Study officials:
References: