Abstract
Background: RCs are common following LR in COPD pts. NIV decreases the rates of tracheal intubation and mortality in post-operative (PO) acute respiratory failure. The aim of our study is to prophylactic NIV for prevention of RCs in the immediate PO care of pts with COPD.
Patients and methods: This multicenter, prospective, randomised, parallel, open ended study planned to enrol 360 pts with moderate to severe COPD scheduled for LR. Patients were randomized to standard treatment without or with NIV during the 3 first PO days. The primary outcome is the incidence of acute respiratory events (AREs), defined as the occurrence of at least two of the following: RR >30/mn, PaO2/FiO2 ≤200 mmHg, >10 mmHg increase in PaCO2 or a new pulmonary infiltrate on chest X Ray. Secondary outcomes are the incidence of RCs, rescue NIV use, invasive ventilation requirements, mortality rate, duration of ICU and hospital stay. Univariate and multivariate analysis will identify subgroups who benefit more from NIV.
Results: 351 pts, 277 men (79%) and 74 women (21%) were effectively included in 6 centres between June 2008 and October 2010. Mean age (±SD) is 62±9 years. Mean pre-operative FEV1 is 62±11% predicted. Pts numbers in GOLD stage II, III and IV are 295 (83.4%), 44 (12.5%) and 4 (1.1%), respectively. There is no difference in baseline patients' characteristics at inclusion between the control group (n = 174) and NIV group (n = 177).
Conclusion: Comparability of the 2 groups at baseline will allow reliable comparisons of outcomes (which will be available at the ERS meeting) between PO NIV and standard care following LR in GOLD stage II-III COPD patients.
- © 2011 ERS