Noninvasive Ventilatory Support After Lung Surgery in COPD Patients (POPVNI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00428857|
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : February 24, 2011
Rationale: respiratory complications are the most frequent complications following lung resection and represent a noticeable cause of mortality. Benefits from non-invasive ventilation (NIV) in acute respiratory failure are now clearly demonstrated. The use of preventive NIV after lung resection, in the absence of acute respiratory failure and/or hypercarbia, could be justified by the physiological benefits expected. The goal of this study is to assess the efficacy of post-operative NIV in moderate-to-severe COPD, for prevention of respiratory complications.
Material and Methods: This is a prospective randomised multicenter trial with an open parallel design in moderate-t-o-severe COPD patients hospitalised in thoracic surgery for lung resection.
Expected results: This study will determine whether post-operative NIV decreases the incidence of acute respiratory events (acute respiratory failure) and whether some subgroups of patients benefit more from this strategy.
Conclusion: This study should help evaluating the utility of post-operative NIV after lung resection.
|Condition or disease||Intervention/treatment||Phase|
|COPD Post Pulmonary Resection||Procedure: non invasive ventilation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
- Procedure: non invasive ventilation
non invasive ventilation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00428857
|Hopital Du Bocage|
|Dijon, France, 21034|
|Paris, France, 75004|
|Institut Mutualiste Montsouris|
|Paris, France, 75014|
|Paris, France, 75015|
|hopital de Pontoise|
|Toulouse, France, 31049|
|Principal Investigator:||christine lorut, MD||APHP|
|Principal Investigator:||antoine rabbat, MD||APHP|