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

This study has been completed.
Information provided by:
Assistance Publique - Hôpitaux de Paris Identifier:
First received: January 29, 2007
Last updated: February 23, 2011
Last verified: January 2007

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 Intervention
COPD Post Pulmonary Resection Procedure: non invasive ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Noninvasive Ventilatory Support After Lung Surgery to Prevent Pulmonary Complications in COPD Patients

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Enrollment: 360
Study Start Date: June 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: non invasive ventilation
    non invasive ventilation

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Yannick VACHER, Department of Clinical Research of developpement Identifier: NCT00428857     History of Changes
Other Study ID Numbers: P070501
Study First Received: January 29, 2007
Last Updated: February 23, 2011 processed this record on June 26, 2017