Abstract
BackgroundThere is no consensus on which lung-protective strategies should be used in cardiac surgery patients. Sparse and small randomized clinical and animal trials suggest that maintaining mechanical ventilation during cardiopulmonary bypass is protective on the lungs. Unfortunately, such evidence is weak as it comes from surrogate and minor clinical endpoints mainly limited to elective coronary surgery. According to the available data in the academic literature, an unquestionable standardized strategy of lung protection during cardiopulmonary bypass cannot be recommended. The purpose of the CPBVENT study is to investigate the effectiveness of different strategies of mechanical ventilation during cardiopulmonary bypass on postoperative pulmonary function and complications.Methods/designThe CPBVENT study is a single-blind, multicenter, randomized controlled trial. We are going to enroll 870 patients undergoing elective cardiac surgery with planned use of cardiopulmonary bypass. Patients will be randomized into three groups: (1) no mechanical ventilation during cardiopulmonary bypass, (2) continuous positive airway pressure of 5 cmH2O during cardiopulmonary bypass, (3) respiratory rate of 5 acts/min with a tidal volume of 2–3 ml/Kg of ideal body weight and positive end-expiratory pressure of 3–5 cmH2O during cardiopulmonary bypass. The primary endpoint will be the incidence of a PaO2/FiO2 ratio <200 until the time of discharge from the intensive care unit. The secondary endpoints will be the incidence of postoperative pulmonary complications and 30-day mortality. Patients will be followed-up for 12 months after the date of randomization.DiscussionThe CPBVENT trial will establish whether, and how, different ventilator strategies during cardiopulmonary bypass will have an impact on postoperative pulmonary complications and outcomes of patients undergoing cardiac surgery.Trial registrationClinicalTrials.gov, ID: NCT02090205. Registered on 8 March 2014.
Highlights
There is no consensus on which lung-protective strategies should be used in cardiac surgery patients
The CPBVENT trial will establish whether, and how, different ventilator strategies during cardiopulmonary bypass will have an impact on postoperative pulmonary complications and outcomes of patients undergoing cardiac surgery
Postoperative pulmonary complications are frequent after cardiac surgery
Summary
Postoperative pulmonary complications are frequent after cardiac surgery. Many factors may contribute to their development, in particular CPB. Feasibility and safety of mechanical ventilation during CPB Many clinical and preclinical trials have demonstrated the feasibility and safety of MV during CPB and introduced the key question of whether ventilating the patient’s lungs during CPB can have an impact on respiratory outcome These are limited to the perioperative period and do not investigate enough clinically relevant endpoints. These results showed the potential effectiveness of mechanical ventilation during CPB to prevent postoperative pulmonary complications (PPCs). The application of low tidal/low frequency ventilation or vital capacity maneuvers during or after CPB was helpful in order to prevent lung injury They found a rather limited impact on postoperative clinical outcomes. All randomized trials take into consideration small-sized samples and limited setting
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