Effects of individualized PEEP on postoperative delirium among older patients in prone position: study protocol for a prospective randomized controlled trial

个体化呼气末正压(PEEP)对俯卧位老年患者术后谵妄的影响:一项前瞻性随机对照试验的研究方案

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Abstract

BACKGROUND: Postoperative delirium (POD) is an acute mental disorder that often occurs in the elderly after surgery. It can delay functional recovery, extend hospital stay, and increase 1-year mortality and financial costs. Studies have shown that inflammation and cerebral desaturation are the potential pathogenesis of postoperative delirium. Prone-position surgery increases peak airway pressure and decreases lung compliance, exacerbating ventilator-induced inflammation response, as well as the decrease of the patient's cerebral oxygen saturation. Recent studies demonstrated that lung-protective ventilation strategy could reduce inflammatory response and improve cerebral oxygen saturation (rSO(2)) to prevent POD. In this trial, we aim to investigate the effect of the individualized PEEP on postoperative delirium in elderly patients during prone position. METHODS: A prospective, randomized clinical trial will be performed in Hebei General Hospital. 106 patients undergoing elective surgery in prone position will be randomly divided into controlled group (group C) and individualized PEEP group (group I). Lung-protective ventilation with tidal volume of 6ml/kg predictive body weight (PBW) and positive end-expiratory pressure (PEEP) of 5 cm H(2)O will be applied to patients in group C. Patients in group I will receive the same tidal volume as described in group C plus individualized PEEP corresponding to the maximum dynamic compliance (Cdyn) in the titration method. Our primary endpoint is the prevalence of postoperative delirium based on the Confusion Assessment Method (CAM) until postoperative day 3. Secondary endpoints include the intraoperative rSO(2), respiratory variables, arterial blood gases, lung ultrasound score (LUS), postoperative VAS score, and plasma concentrations of IL-6, IL-1β and neuron-specific enolase (NSE). DISCUSSION: The results of the current protocol might provide evidence for individualized PEEP to prevent POD among older surgical patients in prone position. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2200056001). Registered 2022 January 30, http://www.chictr.org.cn/index.aspx .

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