Effect of intraoperative oesophageal pressure-guided PEEP on postoperative pulmonary complications in elderly patients undergoing major laparoscopic surgery: study protocol for a multicentre randomised controlled clinical trial in China

Introduction 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-expirato...

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Main Authors: Min Zhu, Jian Yu, Yujia Liu, Jing Zhong, Changhong Miao, Peiyao Xu, Xiushi Zhou, Kefeng Zou, Mengping Wei, Haokang Yang
Format: Article
Language:English
Published: BMJ Publishing Group 2025-08-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/8/e096219.full
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Summary:Introduction 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.Methods and analysis 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 H2O) 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.Ethics and dissemination 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.Protocol version Version 1, on 9 October 2023.Trial registration number NCT06150079.
ISSN:2044-6055