Low tidal volume ventilation during anaesthesia for major surgery: protocol and statistical analysis plan

BACKGROUND: Mechanical ventilation is mandatory in patients undergoing general anaesthesia for major surgery. Tidal volumes higher than 10 mL/kg of predicted body weight have been advocated for intraoperative ventilation, but recent evidence suggests that low tidal volumes may benefit surgical patients. To date, the impact of low tidal volume compared with conventional tidal volume during surgery has only been assessed in clinical trials that also combine different levels of positive end-expiratory pressure (PEEP) in each arm. We aimed to assess the impact of low tidal volume compared with conventional tidal volume during general anaesthesia for surgery on the incidence of postoperative respiratory complications in adult patients receiving moderate levels of PEEP. STUDY DESIGN AND METHODS: Single-centre, two-arm, randomised clinical trial. In total, 1240 adult patients older than 40 years scheduled for at least 2 hours of surgery under general anaesthesia and routinely monitored with an arterial line were included. Patients were ventilated intraoperatively with a moderate level of PEEP (5 cmH2O) and randomly assigned to tidal volume of 6 mL/kg predicted body weight (low tidal volume) or 10 mL/kg predicted body weight (conventional tidal volume in Australia). MAIN OUTCOME MEASURE: The primary outcome is the occurrence of postoperative respiratory complications, recorded as a composite endpoint of adverse respiratory events during the first 7 postoperative days. RESULTS AND CONCLUSIONS: This is the first well powered study comparing the effect of low tidal volume ventilation versus high tidal volume ventilation during surgery on the incidence of postoperative respiratory complications in adult patients receiving moderate levels of PEEP. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ACTRN12614000790640).