Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 360
- Locations
- 7
- Status
- Completed
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with COPD (FEV1 pre-operative \<80% and FEV1/CV\<70%)
- •Patients undergoig pulmonary resection
- •Informed consent
Exclusion Criteria
- •Apnea syndrom and chronic noninvasive support
- •Post-operative extrarespiratory organ failure
- •Inhability to follow study protocole
- •Absence of medical coverage
Outcomes
Primary Outcomes
Not specified