Ventilation strategies with different inhaled Oxygen conceNTration during CardioPulmonary Bypass in cardiac surgery (VONTCPB): study protocol for a randomized controlled trial

BACKGROUND: There is no consensus on the ventilation management during cardiopulmonary bypass (CPB), and the anesthesiologists or the surgeons usually ventilate the lungs with different ventilation strategies or keep them static. Better outcomes are more likely to occur when the ventilation is administered during CPB according to the existing literatures. However, the use of high fraction of inspired oxygen (FiO(2)) is debatable in cardiac surgery. And the potential effects of strategies combining low tidal volume (V(T)) ventilation with different FiO(2) during CPB on postoperative pulmonary complications (PPCs) are unclear. DESIGN: The VONTCPB trial is a single-center, prospective, double-blinded, randomized, controlled trial. We are going to recruit total 420 elective cardiac surgery patients with median sternotomy under CPB, who will be equally randomized into three different ventilation strategy groups: NoV, LOV and HOV. (1) The NoV group receives no mechanical ventilation during CPB; (2) the LOV group receives a low V(T) of 3-4 ml/kg of ideal body weight (IBW) with the respiratory rate (RR) of 10–12 acts/min, and the positive end-expiratory pressure (PEEP) of 5–8 cmH(2)O during CPB; the FiO(2) is 30%; (3) the HOV group receives a low V(T) of 3-4 ml/kg of IBW with the RR of 10–12 acts/min, and the PEEP of 5–8 cmH(2)O during CPB; the FiO(2) is 80%. The primary endpoints are the incidence of the composite of PPCs and the PPCs score. The secondary endpoints refer to the incidence of the oxygenation index (PaO(2)/FiO(2) ratio) < 300 mmHg at three time points (the moment arriving in the ICU, 6 and 12 h after arrival in the ICU), the surgical incision healing grade, the intubation time, the stay of ICU, the length of hospital stay, and mortality at 30 days after the surgery. DISCUSSION: The VONTCPB trial is the first study to assess the effects of strategies combining low tidal volume (V(T)) ventilation with different FiO(2) during CPB on patients’ outcomes. TRIAL REGISTRATION: ChiCTR1800015261. Registered on 20 March 2018. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1186/s13063-019-3335-2) contains supplementary material, which is available to authorized users.