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

Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients

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.

Study Overview

• Status: Completed
• Conditions: COPD; Post Pulmonary Resection
• Intervention / Treatment: Procedure: non invasive ventilation

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21034
    • Hôpital du Bocage
  • Paris, France, 75014
    • Institut Mutualiste Montsouris
  • Paris, France, 75004
    • Hotel Dieu
  • Paris, France, 75015
    • HEGP
  • Pontoise, France
    • hopital de Pontoise
  • Strasbourg, France
    • CHU Strasbourg
  • Toulouse, France, 31049
    • CHU Larrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: christine lorut, MD, APHP; Principal Investigator: antoine rabbat, MD, APHP

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: January 29, 2007
• First Submitted That Met QC Criteria: January 29, 2007
• First Posted (Estimate): January 30, 2007

Study Record Updates

• Last Update Posted (Estimate): February 24, 2011
• Last Update Submitted That Met QC Criteria: February 23, 2011
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Other Study ID Numbers: P070501