Pulmonary EmphysemaBulleEchoNCT04012359
Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax
An observational study of Pulmonary Emphysema, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Emphysema
- What is being tested?
- Lung ultrasound, Chest radiography and Pulmonary function tests
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2019to 26 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Pulmonary Medicine, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital
Rouen, 76000
About this study
Official title: Lung Ultrasound Characterization of Bullous Emphysema
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.
Read more
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.
- Conditions
- Pulmonary Emphysema
- Being tested
- Lung ultrasound, Chest radiography, Pulmonary function tests, Clinical examination
- Keywords
- Lung ultrasound
- Medical subject headings
- Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundDiagnostic test
Non-invasive external ultrasonography of the chest wall
Chest radiographyDiagnostic test
Chest radiography to search for visible pleural edge, synonym with persistent pneumothorax
Pulmonary function testsDiagnostic test
Pulmonary function evaluation as part of routine care for emphysematous patients
Clinical examinationOther
Standard clinical examination performed by investigating physician
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Lung ultrasound; Diagnostic Test: Pulmonary function tests; Other: Clinical examination | |
| Pneumothorax | Participants hospitalized in pulmonary medicine units for the treatment of a pneumothorax will undergo lung ultrasound according to standard of care clinical practice. Receives: Diagnostic Test: Lung ultrasound; Diagnostic Test: Chest radiography; Other: Clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
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
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start26 Jun 2019
- Primary completion26 Jun 2021
- Study completion26 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmphysemaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012359
- Sponsor's protocol ID
- 2019/006/OB
- Acronym
- BulleEcho
- Status last verified
- Nov 2022
- First submitted
- 24 May 2019
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El Husseini K, Flament T, Laroumagne S, Basille D, Le Brun M, Noel-Savina E, Richard P, Mangiapan G, Artaud-Macari E. Mapping Bullous Emphysema With Lung Ultrasound: A Prospective Multicentre Study. Respirology. 2025 Jul;30(7):633-643. doi: 10.1111/resp.70021. Epub 2025 Mar 9.
PubMed 40059443
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound Characterization of Bullous Emphysema
- ClinicalTrials.gov ID
- NCT04012359
- Acronym / sponsor ID
- BulleEcho / 2019/006/OB
- Conditions
- Pulmonary Emphysema
- Keywords
- Lung ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 26 Jun 2021 (actual)
- Study completion
- 26 Jun 2021 (actual)
- First posted
- 9 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bullous emphysema | – | Diagnostic Test: Lung ultrasound, Diagnostic Test: Pulmonary function tests, Other: Clinical examinationParticipants with known bullous emphysema will undergo lung ultrasound according to standard of care clinical practice during a regular follow-up consultation or scheduled hospitalization. |
| Pneumothorax | – | Diagnostic Test: Lung ultrasound, Diagnostic Test: Chest radiography, Other: Clinical examinationParticipants hospitalized in pulmonary medicine units for the treatment of a pneumothorax will undergo lung ultrasound according to standard of care clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Bullous emphysema group
- Pneumothorax group
Key exclusion criteria (8 listed)
- Bullous emphysema group
- All patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundNon-invasive external ultrasonography of the chest wall | Diagnostic test | Bullous emphysema, Pneumothorax |
| Chest radiographyChest radiography to search for visible pleural edge, synonym with persistent pneumothorax | Diagnostic test | Pneumothorax |
| Pulmonary function testsPulmonary function evaluation as part of routine care for emphysematous patients | Diagnostic test | Bullous emphysema |
| Clinical examinationStandard clinical examination performed by investigating physician | Other | Bullous emphysema, Pneumothorax |
Primary outcome
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 : * 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
2 secondary outcomes
Prevalence of various ultrasound signs in the pneumothorax group, according to a predetermined sonographic evaluation form, following a standardized segmentation of the chest
Time frame: 2 years
Statistical comparison of ultrasound characteristics of bullous emphysema and pneumothorax
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Derived from this study: PubMed 40059443El Husseini K, Flament T, Laroumagne S, Basille D, Le Brun M, Noel-Savina E, Richard P, Mangiapan G, Artaud-Macari E. Mapping Bullous Emphysema With Lung Ultrasound: A Prospective Multicentre Study. Respirology. 2025 Jul;30(7):633-643. doi: 10.1111/resp.70021. Epub 2025 Mar 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Emphysema, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04012359, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.