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

NCT04012359 | Completed

• 1 other identifier: 2019/006/OB
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Emphysema

Keywords

Lung ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

  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

  2 years

• Statistical comparison of ultrasound characteristics of bullous emphysema and pneumothorax

  2 years

Study Arms (2)

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.

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.

Diagnostic Test: Lung ultrasound; Diagnostic Test: Chest radiography; Other: Clinical examination

Interventions

Lung ultrasound DIAGNOSTIC_TEST

Non-invasive external ultrasonography of the chest wall

Bullous emphysema; Pneumothorax

Chest radiography DIAGNOSTIC_TEST

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

Pneumothorax

Pulmonary function tests DIAGNOSTIC_TEST

Pulmonary function evaluation as part of routine care for emphysematous patients

Bullous emphysema

Clinical examination OTHER

Standard clinical examination performed by investigating physician

Bullous emphysema; Pneumothorax

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

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

Rouen, 76000, France

Location

Related Publications (1)

• 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.

  PMID: 40059443 DERIVED

MeSH Terms

Conditions

Pulmonary Emphysema

Interventions

Diagnostic Imaging; Respiratory Function Tests; Restraint, Physical

Condition Hierarchy (Ancestors)

Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: July 9, 2019
• Study Start: June 26, 2019
• Primary Completion: June 26, 2021
• Study Completion: June 26, 2021
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

FR (1)