An observational study in Pulmonary Emphysema, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by University Hospital, Rouen · Observational
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.
187 studies on the registry are indexed under Pulmonary Emphysema; 19 are open to participants now.
This study's enrollment of 35 is below the median of 74 across 48 observational studies indexed under Pulmonary Emphysema.
Browse Pulmonary Emphysema studies →University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
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Participants will be recruited from multiple Pulmonary Departments in France, in the setting of University Hospitals. All participants fulfilling inclusion criteria will be included.
Bullous emphysema group
Pneumothorax group
Exclusion Criteria:
Bullous emphysema group
All patients
Participants with known bullous emphysema will undergo lung ultrasound according to standard of care clinical practice during a regular follow-up consultation or scheduled hospitalization.
Diagnostic Test: Lung ultrasound · Diagnostic Test: Pulmonary function tests · Other: Clinical examination
Participants hospitalized in pulmonary medicine units for the treatment of a pneumothorax will undergo lung ultrasound according to standard of care clinical practice.
Diagnostic Test: Lung ultrasound · Diagnostic Test: Chest radiography · Other: Clinical examination
Non-invasive external ultrasonography of the chest wall
Chest radiography to search for visible pleural edge, synonym with persistent pneumothorax
Pulmonary function evaluation as part of routine care for emphysematous patients
Standard clinical examination performed by investigating physician
Prevalence of various ultrasound signs in the bullous emphysema group, according to a predetermined sonographic evaluation form, following a standardized segmentation of the chest
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
Time frame: 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
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
Time frame: 2 years
Statistical comparison of ultrasound characteristics of bullous emphysema and pneumothorax
* Calculation of sensitivity values of lung ultrasound for bullous emphysema for each sonographic sign. Study design prohibits calculation of specificity. * A quantitative discrete score will be constructed by enumerating signs which are positive in favor of bullous emphysema, able to discriminate between both diseases. AUC will be calculated. An AUC \< 0.75 will be considered as insufficient for establishing lung ultrasound as a diagnostic test for bullous emphysema. An AUC \> 0.75 would prompt further studies.
Time frame: 2 years
Plan to share: Undecided
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Rouen