Noninvasive Ventilatory Support After Lung Surgery in COPD Patients
POPVNI
1 other identifier
interventional
360
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2008
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2007
CompletedFirst Posted
Study publicly available on registry
January 30, 2007
CompletedStudy Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedFebruary 24, 2011
January 1, 2007
2.3 years
January 29, 2007
February 23, 2011
Conditions
Interventions
non invasive ventilation
Eligibility Criteria
You may qualify if:
- Patients with COPD (FEV1 pre-operative \<80% and FEV1/CV\<70%)
- Patients undergoig pulmonary resection
- Informed consent
You may not qualify if:
- Apnea syndrom and chronic noninvasive support
- Post-operative extrarespiratory organ failure
- Inhability to follow study protocole
- Absence of medical coverage
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hopital Du Bocage
Dijon, Dijon, 21034, France
HEGP
Paris, Paris, 75015, France
hopital de Pontoise
Pontoise, Pontoise, France
CHU strasbourg
Strasbourg, Strasbourg, France
Hotel Dieu
Paris, 75004, France
Institut Mutualiste Montsouris
Paris, 75014, France
CHU Larrey
Toulouse, 31049, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
christine lorut, MD
APHP
- PRINCIPAL INVESTIGATOR
antoine rabbat, MD
APHP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 29, 2007
First Posted
January 30, 2007
Study Start
June 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 24, 2011
Record last verified: 2007-01