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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00428857
Recruitment Status : Completed
First Posted : January 30, 2007
Last Update Posted : February 24, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
COPD Post Pulmonary Resection Procedure: non invasive ventilation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients
Study Start Date : June 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Intervention Details:
  • Procedure: non invasive ventilation
    non invasive ventilation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00428857

Hopital Du Bocage
Dijon, France, 21034
Hotel Dieu
Paris, France, 75004
Institut Mutualiste Montsouris
Paris, France, 75014
Paris, France, 75015
hopital de Pontoise
Pontoise, France
CHU strasbourg
Strasbourg, France
CHU Larrey
Toulouse, France, 31049
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: christine lorut, MD APHP
Principal Investigator: antoine rabbat, MD APHP

Responsible Party: Yannick VACHER, Department of Clinical Research of developpement Identifier: NCT00428857     History of Changes
Other Study ID Numbers: P070501
First Posted: January 30, 2007    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: January 2007