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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00428857
First received: January 29, 2007
Last updated: February 23, 2011
Last verified: January 2007
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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
    Other Name: non invasive ventilation
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00428857

Locations
France
Hopital Du Bocage
Dijon, France, 21034
Institut Mutualiste Montsouris
Paris, France, 75014
Hotel Dieu
Paris, France, 75004
HEGP
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
Investigators
Principal Investigator: christine lorut, MD APHP
Principal Investigator: antoine rabbat, MD APHP
  More Information

No publications provided

Responsible Party: Yannick VACHER, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00428857     History of Changes
Other Study ID Numbers: P070501
Study First Received: January 29, 2007
Last Updated: February 23, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014