Noninvasive Ventilatory Support After Lung Surgery in COPD Patients

COPD Clinical Trial

— POPVNI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00428857
• Other study ID #: P070501
• Status: Completed
• Phase: N/A
• First received: January 29, 2007
• Last updated: February 23, 2011
• Start date: June 2008
• Est. completion date: October 2010

Study information

• Verified date: January 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• COPD
• Post Pulmonary Resection

Intervention

Procedure:
• non invasive ventilation
non invasive ventilation

Locations

Country	Name	City	State
France	Hopital Du Bocage	Dijon
France	HEGP	Paris
France	Hotel Dieu	Paris
France	Institut Mutualiste Montsouris	Paris
France	hopital de Pontoise	Pontoise
France	CHU strasbourg	Strasbourg
France	CHU Larrey	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France,