Back to resultsForced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome (OSCILLOPOUMON)
Primary Purpose
Bronchiolitis Obliterans Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Forced oscillation
Sponsored by
About this trial
This is an interventional diagnostic trial for Bronchiolitis Obliterans Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients of more than 18 year-old.
- Patients with cardiopulmonary transplant or bilateral lung transplant.
- Clinically stable patients
Exclusion Criteria:
- Patients already diagnosed with bronchiolitis obliterans.
- Respiratory infection.
- Acute graft rejection.
- Mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion).
- Iatrogenic pneumopathy.
- Inability to perform Respiratory function test.
Sites / Locations
- Hôpital FOCH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
post allogreffe patients
Arm Description
Functional evaluation of distal airway by forced oscillation technique : relevance earlier diagnostic of pulmonary syndrom of oblitérant bronchiolit in post allogreffe patients
Outcomes
Primary Outcome Measures
Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01807975
Brief Title
Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome
Acronym
OSCILLOPOUMON
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
4. Oversight
5. Study Description
Brief Summary
A study to evaluate the role of forced oscillation in precocious diagnosis of bronchiolitis obliterans syndrome in patients with pulmonary transplant (time difference in detecting distal airways functional impairment by forced oscillation and the standard technique using spirometry).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis Obliterans Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
post allogreffe patients
Arm Type
Experimental
Arm Description
Functional evaluation of distal airway by forced oscillation technique : relevance earlier diagnostic of pulmonary syndrom of oblitérant bronchiolit in post allogreffe patients
Intervention Type
Other
Intervention Name(s)
Forced oscillation
Primary Outcome Measure Information:
Title
Time difference in diagnosing distal airways functional disturbance by forced oscillation and by spirometry (standard methode).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of more than 18 year-old.
Patients with cardiopulmonary transplant or bilateral lung transplant.
Clinically stable patients
Exclusion Criteria:
Patients already diagnosed with bronchiolitis obliterans.
Respiratory infection.
Acute graft rejection.
Mechanical complications (bronchial dehiscence, pneumothorax, pleural effusion).
Iatrogenic pneumopathy.
Inability to perform Respiratory function test.
Facility Information:
Facility Name
Hôpital FOCH
City
Suresnes
State/Province
Ile de France
ZIP/Postal Code
92150
Country
France
12. IPD Sharing Statement
Learn more about this trial
Forced Oscillation Versus Spirometry in Diagnosing Post Pulmonary Transplant Bronchiolitis Obliterans Syndrome
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