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出境医 / 临床实验 / Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax (BulleEcho)

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

Study Description
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.


Condition or disease Intervention/treatment
Pulmonary Emphysema Diagnostic Test: Lung ultrasound Diagnostic Test: Chest radiography Diagnostic Test: Pulmonary function tests Other: Clinical examination

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Lung Ultrasound Characterization of Bullous Emphysema
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021
Arms 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

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

Other: Clinical examination
Standard clinical examination performed by investigating physician

Outcome Measures
Primary Outcome Measures :
  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 [ 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



Secondary Outcome Measures :
  1. 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 ]

    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. Statistical comparison of ultrasound characteristics of bullous emphysema and pneumothorax [ Time Frame: 2 years ]
    • 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations

Locations
Layout table for location information
France
Pulmonary Medicine, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital Recruiting
Rouen, France, 76000
Contact: ARTAUD-MACARI Elise, MD    +33232888990    Elise.Artaud-Macari@chu-rouen.fr   
Contact: EL HUSSEINI Kinan, MD    +33612194393    kinelhu@gmail.com   
Principal Investigator: Kinan EL HUSSEINI         
Sponsors and Collaborators
University Hospital, Rouen
Tracking Information
First Submitted Date May 24, 2019
First Posted Date July 9, 2019
Last Update Posted Date April 29, 2021
Actual Study Start Date June 26, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2019)
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
Original Primary Outcome Measures
 (submitted: July 4, 2019)
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, we will present proportions Quantitative signs will be reported using means, medians and standard-deviations
Change History
Current Secondary Outcome Measures
 (submitted: July 15, 2019)
  • 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 ]
    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
  • Statistical comparison of ultrasound characteristics of bullous emphysema and pneumothorax [ Time Frame: 2 years ]
    • 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.
Original Secondary Outcome Measures
 (submitted: July 4, 2019)
  • 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 ]
    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, we will present proportions Quantitative signs will be reported using means, medians and standard-deviations
  • Statistical comparison of ultrasound characteristics of bullous emphysema and pneumothorax [ Time Frame: 2 years ]
    • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax
Official Title Lung Ultrasound Characterization of Bullous Emphysema
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Pulmonary Emphysema
Intervention
  • Diagnostic Test: Lung ultrasound
    Non-invasive external ultrasonography of the chest wall
  • Diagnostic Test: Chest radiography
    Chest radiography to search for visible pleural edge, synonym with persistent pneumothorax
  • 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
Study Groups/Cohorts
  • 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.
    Interventions:
    • 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.
    Interventions:
    • Diagnostic Test: Lung ultrasound
    • Diagnostic Test: Chest radiography
    • Other: Clinical examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 4, 2019)
35
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04012359
Other Study ID Numbers 2019/006/OB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party University Hospital, Rouen
Study Sponsor University Hospital, Rouen
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Rouen
Verification Date April 2021

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