Noninvasive Ventilatory Support After Lung Surgery in COPD Patients (POPVNI)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Post Pulmonary Resection; COPD

Treatments: Procedure: non invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00428857

P070501

Details and patient eligibility

About

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.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)