METHODS: Patients undergoing general anesthesia and endotracheal intubation with volume-controlled ventilation with a tidal volume of 7 ml per kg predicted body weight will be randomized and assigned to either an intervention group with PEEP adjusted according to BMI or a control group with a standardized PEEP of 5 mbar. Pre- and postoperatively, lung ultrasound will be performed to determine the lung aeration score, and hemodynamic and respiratory vital signs will be recorded for subsequent evaluation. The primary outcome is the difference in ΔP as a surrogate parameter for lung-protective ventilation. Secondary outcomes include change in lung aeration score, intraoperative occurrence of hemodynamic and respiratory events, oxygen requirements and postoperative pulmonary complications.
CONCLUSIONS: The study results will show whether an intraoperative ventilation strategy with PEEP adjustment based on BMI has the potential of reducing the risk for postoperative pulmonary complications as an easy-to-implement intervention that does not require lengthy ventilator maneuvers nor additional equipment.
BACKGROUND: German Clinical Trials Register (DRKS), DRKS00031336. Registered 21st February 2023.
METHODS: The study protocol was approved by the ethics committee of the Christian-Albrechts-Universität Kiel, Germany, on 1st February 2023. Recruitment began in March 2023 and is expected to end in September 2023.
方法:将接受全身麻醉和气管插管的患者进行容量控制通气,潮气量为7ml/kg预测体重,并随机分配给根据BMI调整PEEP的干预组或标准PEEP为5mbar的对照组。术前和术后,将进行肺超声检查以确定肺通气评分,血液动力学和呼吸生命体征将被记录用于后续评估。主要结果是ΔP作为肺保护性通气的替代参数的差异。次要结果包括肺通气评分的变化,术中血流动力学和呼吸事件的发生,氧需求和术后肺部并发症。
结论:研究结果将表明,基于BMI调整PEEP的术中通气策略是否具有降低术后肺部并发症风险的潜力,作为一种易于实施的干预措施,不需要长时间的呼吸机操作,也不需要额外的设备。
背景:德国临床试验注册(DRKS),DRKS00031336。2023年2月21日注册。
方法:研究方案得到了基尔基督教-阿尔布雷希茨大学伦理委员会的批准,德国,2023年2月1日招聘始于2023年3月,预计将于2023年9月结束。