Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax

NCT ID: NCT04012359

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-26

Study Completion Date

2021-06-26

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Emphysema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lung ultrasound

Intervention Type DIAGNOSTIC_TEST

Non-invasive external ultrasonography of the chest wall

Pulmonary function tests

Intervention Type DIAGNOSTIC_TEST

Pulmonary function evaluation as part of routine care for emphysematous patients

Clinical examination

Intervention Type OTHER

Standard clinical examination performed by investigating physician

Pneumothorax

Participants hospitalized in pulmonary medicine units for the treatment of a pneumothorax will undergo lung ultrasound according to standard of care clinical practice.

Lung ultrasound

Intervention Type DIAGNOSTIC_TEST

Non-invasive external ultrasonography of the chest wall

Chest radiography

Intervention Type DIAGNOSTIC_TEST

Chest radiography to search for visible pleural edge, synonym with persistent pneumothorax

Clinical examination

Intervention Type OTHER

Standard clinical examination performed by investigating physician

Interventions

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Lung ultrasound

Non-invasive external ultrasonography of the chest wall

Intervention Type DIAGNOSTIC_TEST

Chest radiography

Chest radiography to search for visible pleural edge, synonym with persistent pneumothorax

Intervention Type DIAGNOSTIC_TEST

Pulmonary function tests

Pulmonary function evaluation as part of routine care for emphysematous patients

Intervention Type DIAGNOSTIC_TEST

Clinical examination

Standard clinical examination performed by investigating physician

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pulmonary Medicine, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 40059443 (View on PubMed)

Other Identifiers

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2019/006/OB

Identifier Type: -

Identifier Source: org_study_id

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