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.
Condition or disease | Intervention/treatment |
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Pulmonary Emphysema | Diagnostic Test: Lung ultrasound Diagnostic Test: Chest radiography Diagnostic Test: Pulmonary function tests Other: Clinical examination |
Study Type : | Observational |
Estimated Enrollment : | 35 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Lung Ultrasound Characterization of Bullous Emphysema |
Actual Study Start Date : | June 26, 2019 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | July 2021 |
Group/Cohort | Intervention/treatment |
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Bullous emphysema
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.
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Diagnostic Test: Lung ultrasound
Non-invasive external ultrasonography of the chest wall
Diagnostic Test: Pulmonary function tests Pulmonary function evaluation as part of routine care for emphysematous patients
Other: Clinical examination Standard clinical examination performed by investigating physician
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Pneumothorax
Participants hospitalized in pulmonary medicine units for the treatment of a pneumothorax will undergo lung ultrasound according to standard of care clinical practice.
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Diagnostic Test: Lung ultrasound
Non-invasive external ultrasonography of the chest wall
Diagnostic Test: Chest radiography Chest radiography to search for visible pleural edge, synonym with persistent pneumothorax
Other: Clinical examination Standard clinical examination performed by investigating physician
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The following sonographic signs will be investigated :
For qualitative signs, the investigators will present proportions Quantitative signs will be reported using means, medians and standard-deviations
The following sonographic signs will be investigated :
For qualitative signs, the investigators will present proportions Quantitative signs will be reported using means, medians and standard-deviations
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Bullous emphysema group
Pneumothorax group
Exclusion Criteria:
Bullous emphysema group
All patients
France | |
Pulmonary Medicine, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital | Recruiting |
Rouen, France, 76000 | |
Contact: ARTAUD-MACARI Elise, MD +33232888990 Elise.Artaud-Macari@chu-rouen.fr | |
Contact: EL HUSSEINI Kinan, MD +33612194393 kinelhu@gmail.com | |
Principal Investigator: Kinan EL HUSSEINI |
Tracking Information | |||||
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First Submitted Date | May 24, 2019 | ||||
First Posted Date | July 9, 2019 | ||||
Last Update Posted Date | April 29, 2021 | ||||
Actual Study Start Date | June 26, 2019 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Prevalence of various ultrasound signs in the bullous emphysema group, according to a predetermined sonographic evaluation form, following a standardized segmentation of the chest [ Time Frame: 2 years ] The following sonographic signs will be investigated :
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Original Primary Outcome Measures |
Prevalence of various ultrasound signs in the bullous emphysema group, according to a predetermined sonographic evaluation form, following a standardized segmentation of the chest [ Time Frame: 2 years ] The following sonographic signs will be investigated :
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Change History | |||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax | ||||
Official Title | Lung Ultrasound Characterization of Bullous Emphysema | ||||
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. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
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. | ||||
Condition | Pulmonary Emphysema | ||||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
35 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | July 2021 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | |||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04012359 | ||||
Other Study ID Numbers | 2019/006/OB | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | University Hospital, Rouen | ||||
Study Sponsor | University Hospital, Rouen | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | University Hospital, Rouen | ||||
Verification Date | April 2021 |