Introduction: Patients who undergo major cardiac surgery are at risk of developing Ventilator Associated Pneumonia (VAP). The Venner PneuX Y.P.VAP Prevention system has been developed specifically with the aim of reducing the incidence of VAP. This system is comprised of an endotracheal tube with subglottic ports to allow irrigation and suction of the subglottic space as well as a cuff pressure monitoring system to enable continuous in vivo monitoring and maintenance of the endotracheal tube cuff at a preselected pressure. Initial case series using this system have reported promising results in reducing the incidence of VAP. However to date there has been no randomised controlled trial to scentifically evaluate the efficacy of the Venner PneuX Y.P. VAP Prevention system to reduce the incidence of VAP compared to a standard endotracheal tube in high risk patients scheduled for major heart surgery. Methods: 240 high risk patients (age >70 years and/or impaired left ventricular function with ejection fraction <40%) who were scheduled for elective or urgent cardiac surgery were randomly assigned to be intubated with the Venner PneuX Y.P. VAP Prevention system tube or a standard endotracheal tube at induction of anaesthesia. Patients were monitored up for up to 48hours following extubation for the development of VAP. VAP was diagnosed as per the HELICS definition. The incidence of VAP between the two groups was the primary outcome measure. Results: There were no significant differences between the two groups in terms of pre-operative patient demographics. The mean (SD) age was 72.4 (8.2) and 72.2 years (7.4) respectively (p=0.6). Pre-operatively 16.7% and 18.5% (0.7) of patients respectively had a history of lung disease (COPD or Asthma) p=0.6. The mean Euroscores were 6.39 (2.2) and 6.48 (2.6) respectively (p=0.9). There were no differences in the types of cardiac procedures with 28.6% and 25.2% (p=0.3) of patients undergoing complex operation (CABG+Valve, multiple valve surgery). The median duration of endotracheal intubation were 15.1 and 13.1 hours respectively (p=0.3). The incidence of VAP was significantly lower in patients intubated with the Venner PneuX Y.P.VAP Prevention system compared to a standard endotracheal tube (10.8% V/S 21%) in this high-risk patient group (p=0.031). There was no significant difference in the ICU stay (p=0.2). Post-op survival was similar in both groups (97% V/S 99%; p=0.2). Multivariate regression analysis taking into account type of ET tube, age, Left Ventricular Ejection Fraction, Euroscore, history of lung disease, recent MI, in-hospital stay prior to surgery, type of cardiac procedure, urgency of surgery, re-exploration for bleeding, duration of ET intubation confirmed that the Venner PneuX Y.P. VAP Prevention system as the only significant factor to reduce VAP (odds ratio 2.2, p=0.03). Conclusions: The the Venner PneuX Y.P. VAP Prevention system reduces the risk of VAP in high-risk patients undergoing cardiac surgery despite a short intubation time.
(C) 2013 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins