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

• Published in: Current controlled trials in cardiovascular medicine 2019-05, Vol.20 (1), p.254-254, Article 254
• Main Authors: Zhang, Meng-Qiu, Liao, Yu-Qi, Yu, Hong, Li, Xue-Fei, Feng, Liang, Yang, Xiao-Yun, Yu, Hai
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Analysis; Anesthesiologists; Body weight; Cardiac Surgical Procedures - adverse effects; Cardiopulmonary bypass; Cardiopulmonary Bypass - adverse effects; China; Clinical trials; Coronary artery bypass; Double-Blind Method; Edema; Heart surgery; Hospital patients; Humans; Hyperoxia; Infections; Ischemia; Length of stay; Low tidal volume; Lungs; Mechanical ventilation, Oxygen concentration; Mortality; Oxygen - administration & dosage; Oxygen - adverse effects; Oxygen Inhalation Therapy - adverse effects; Physicians; Pleural effusion; Pneumothorax; Postoperative Complications - etiology; Postoperative pulmonary complications; Practice; Prospective Studies; Randomized Controlled Trials as Topic; Respiration, Artificial - adverse effects; Respiration, Artificial - methods; Risk Factors; Study Protocol; Surgery; Thoracentesis; Time Factors; Treatment Outcome; Ventilators
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3335-2

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 ) is debatable in cardiac surgery. And the potential effects of strategies combining low tidal volume (V ) ventilation with different FiO during CPB on postoperative pulmonary complications (PPCs) are unclear. 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 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 O during CPB; the FiO is 30%; (3) the HOV group receives a low V of 3-4 ml/kg of IBW with the RR of 10-12 acts/min, and the PEEP of 5-8 cmH O during CPB; the FiO 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 /FiO ratio)