Noninvasive Ventilatory Support After Lung Surgery in COPD Patients

Not Applicable

Completed

• Conditions: COPD; Post Pulmonary Resection

• Registration Number: NCT00428857
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-01
• Study First Submitted: 2007-01-29
• Study First Submitted QC: 2007-01-29
• Study First Posted: 2007-01-30
• Study Start: 2008-06
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2011-02-23
• Last Update Posted: 2011-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients with COPD (FEV1 pre-operative <80% and FEV1/CV<70%)
• Patients undergoig pulmonary resection
• Informed consent

Read More

Exclusion Criteria

• Apnea syndrom and chronic noninvasive support
• Post-operative extrarespiratory organ failure
• Inhability to follow study protocole
• Absence of medical coverage

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (7)

Hopital Du Bocage; 🇫🇷 Dijon, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

HEGP; 🇫🇷 Paris, France

CHU strasbourg; 🇫🇷 Strasbourg, France

Hotel Dieu; 🇫🇷 Paris, France

CHU Larrey; 🇫🇷 Toulouse, France

hopital de Pontoise; 🇫🇷 Pontoise, France