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Clinical Trials/NCT00428857
NCT00428857
Completed
Not Applicable

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

Assistance Publique - Hôpitaux de Paris7 sites in 1 country360 target enrollmentJune 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
360
Locations
7
Status
Completed
Last Updated
15 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
October 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Not specified

Study Sites (7)

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