Late Breaking Abstract - Pre-operative Non Invasive Ventilation (NIV) does not decrease post-operative complication rate after carcinologic lung surgery : the preOVNI GFPC 12-01 randomized controlled study.

Background: In small sample studies, peri-operative NIV seems to decrease the complication rate (CR) but systematic post-operative NIV did not. The preOVNI study investigated wether pre-operative NIV could reduce the CR after lung cancer surgery. Materials and methods: RC open-labelled study. IC : >18 years-old, planned surgery for lung cancer and at least 1 cardiac or respiratory comorbidity (COPD≥2, restriction, BMI≥30, cardiac insuffisiency or atrial fibrillation), no previous NIV. Patients were 1:1 randomly assigned to NIV (≥7 days and 4h/day) before the planned surgery, or no NIV. Treatment was started to the hospital and continued at home. Parameters were suggested. Main criteria : post operative CR (precisely defined and adjudicated by an independant blinded committee). 300 patients had to be included (estimated CR 30%, bilateral α-risk 5%, power 83%). Results: Among 300 included patients (NIV group 153 and no NIV group 147), 284 (96%) were analyzable for the main criteria. There was no difference in terms of presentation and management between groups. 66% of NIV patients had a median duration of NIV>4h. The CR were 42,6% (NIV) vs 44,8% (no NIV), p=0,75. There was a trend towards a decrease rate of pneumopathies with NIV (p=0,08). No subgroup of patients seem to benefit of NIV. Multivariate analysis found no effect of the type of surgery. The estimated rate of OSA was 23%. Recent smoking cessation seems to be at risk for complications. Conclusion: This study found no benefit of pre-operative NIV before lung cancer surgery. Further study should evaluate NIV + pulmonary rehabilitation.