Completed

BulleEchoLung Ultrasound Characterization of Bullous Emphysema

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Chronic Disease+6

+ Lung Diseases

+ Lung Diseases, Obstructive

Over 18 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: June 2019
See protocol details

Summary

Principal SponsorUniversity Hospital, Rouen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 26, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleLung Ultrasound Characterization of Bullous Emphysema
NCT04012359
Principal SponsorUniversity Hospital, Rouen
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

35 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesPulmonary EmphysemaRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

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

Rouen, FranceOpen Pulmonary Medicine, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital in Google Maps
CompletedOne Study Center
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