Zhong Jing, Xu Peiyao, Zhou Xiushi, Zou Kefeng, Yu Jian, Liu Yujia, Zhu Min, Wei Mengping, Yang Haokang, Miao Changhong
Department of Anesthesiology, Zhongshan Hospital Fudan University, Shanghai, China.
Department of Anesthesiology, Shanghai Geriatric Medical Center, Shanghai, China.
BMJ Open. 2025 Aug 13;15(8):e096219. doi: 10.1136/bmjopen-2024-096219.
Postoperative pulmonary complications (PPCs) induced by mechanical ventilation in general anaesthesia are related to poor clinical outcomes. Positive end-expiratory pressure (PEEP) is a key component of the lung protective ventilation strategy. Individualised PEEP guided by end-expiratory oesophageal pressure (Pes) to maintain a positive end-expiratory transpulmonary pressure can avoid alveolar collapse and improve the respiratory mechanics. However, there is no research studying the relationship between the Pes-guided PEEP titration and PPCs. The aim of our study is to investigate the potential role of Pes-guided PEEP titration on the incidence of PPCs and respiratory mechanics.
A total of 232 elderly patients undergoing major laparoscopic surgery under general anaesthesia will be recruited in four tertiary teaching hospitals in China. Patients will be randomly allocated to the control group (PEEP set at 3 cm HO) without lung recruitment manoeuvres (RMs) or Pes-guided PEEP group with RMs in a 1:1 ratio. Preoperative preparation, anaesthesia management and postoperative care will be performed similarly in both groups. The primary outcome will be the development of PPCs within 7 days after surgery. The intraoperative respiratory parameters, the oxygenation index, vital signs and non-respiratory complications within 7 days after surgery, the 15-item Quality of Recovery-15 questionnaire, unplanned reintubation and unplanned transfer to the intensive care unit, hospital stay, perioperative plasma levels of lung injury biomarkers, complications within 30 days after surgery and 90-day mortality after surgery will be recorded and evaluated as the secondary outcomes.
The study has received ethics approval from the ethics committee of the Zhongshan Hospital, Fudan University (China) with the approval number B2023-334R. The results of the study will be submitted for publication in peer-reviewed journals.
Version 1, on 9 October 2023.
NCT06150079.
全身麻醉中机械通气引起的术后肺部并发症（PPCs）与不良临床结局相关。呼气末正压（PEEP）是肺保护性通气策略的关键组成部分。以呼气末食管压力（Pes）为指导进行个体化PEEP以维持呼气末跨肺压为正值，可避免肺泡塌陷并改善呼吸力学。然而，尚无研究探讨Pes指导的PEEP滴定与PPCs之间的关系。本研究的目的是探讨Pes指导的PEEP滴定对PPCs发生率和呼吸力学的潜在作用。
在中国的四家三级教学医院招募232例接受全身麻醉下大型腹腔镜手术的老年患者。患者将按1:1比例随机分配至对照组（PEEP设定为3 cm H₂O）且不进行肺复张手法（RMs）或接受有RMs的Pes指导的PEEP组。两组的术前准备、麻醉管理和术后护理将相似进行。主要结局将是术后7天内PPCs的发生情况。术中呼吸参数、术后7天内的氧合指数、生命体征和非呼吸并发症、15项恢复质量-15问卷、计划外重新插管和计划外转入重症监护病房、住院时间、围手术期肺损伤生物标志物的血浆水平、术后30天内的并发症以及术后90天死亡率将被记录并作为次要结局进行评估。
本研究已获得复旦大学附属中山医院伦理委员会的伦理批准（中国），批准号为B2023 - 334R。研究结果将提交至同行评审期刊发表。
2023年10月9日第1版。
NCT06150079。
