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

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.

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 Overview

• Status: Completed
• Conditions: Pulmonary Emphysema
• Intervention / Treatment: Diagnostic test: Lung ultrasound; Diagnostic test: Pulmonary function tests; Other: Clinical examination; Diagnostic test: Chest radiography

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • Pulmonary Medicine, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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
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; Non-invasive external ultrasonography of the chest wall; Other: Clinical examination; Standard clinical examination performed by investigating physician; Diagnostic test: Chest radiography; Chest radiography to search for visible pleural edge, synonym with persistent pneumothorax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Rouen

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): June 26, 2021
• Study Completion (Actual): June 26, 2021

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Lung ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: 2019/006/OB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No