Aranake-Chrisinger Amrita, Cheng Jenny Zhao, Muench Maxwell R, Tang Rose, Mickle Angela, Maybrier Hannah, Lin Nan, Wildes Troy, Lenze Eric, Avidan Michael Simon
Department of Anesthesiology, Washington University School of Medicine in St. Louis, Saint Louis, Missouri, USA.
Kirksville College of Osteopathic Medicine, Kirksville, Missouri, USA.
BMJ Open. 2018 Mar 17;8(3):e017079. doi: 10.1136/bmjopen-2017-017079.
Postoperative delirium (POD) is a common complication in elderly patients, characterised by a fluctuating course of altered consciousness, disordered thinking and inattention. Preliminary research has linked POD with persistent cognitive impairment and decreased quality of life. However, these findings maybe confounded by patient comorbidities, postoperative complications and frailty. Our objective is to determine whether POD is an independent risk factor for persistent impairments in attention and executive function after elective surgery. Our central hypothesis is that patients with POD are more likely to have declines in cognition and quality of life 1 year after surgery compared with patients without POD. We aim to clarify whether these associations are independent of potentially confounding factors. We will also explore the association between POD and incident dementia.
This study will recruit 200 patients from the ongoing Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study. Patients who live ≤45 miles from the study centre or have a planned visit to the centre 10-16 months postoperatively will be eligible. Patients with POD, measured by the Confusion Assessment Method, will be compared with patients without delirium. The primary outcome of cognitive function and secondary outcomes of quality of life and incident dementia will be compared between cohorts. Cognition will be measured by Trails A and B and Stroop Color and Word Test, quality of life with Veteran's RAND 12-item Health Survey and incident dementia with the Short Blessed Test. Multivariable regression analyses and a Cox proportional hazards analysis will be performed. All results will be reported with 95% CIs and α=0.05.
The study has been approved by the Washington University in St. Louis Institutional Review Board (IRB no 201601099). Plans for dissemination include scientific publications and presentations at scientific conferences.
NCT02241655.
术后谵妄(POD)是老年患者常见的并发症,其特征为意识改变、思维紊乱和注意力不集中的波动病程。初步研究已将POD与持续性认知障碍及生活质量下降联系起来。然而,这些发现可能会受到患者合并症、术后并发症和虚弱的影响。我们的目的是确定POD是否为择期手术后注意力和执行功能持续性损害的独立危险因素。我们的核心假设是,与无POD的患者相比,有POD的患者在术后1年更有可能出现认知和生活质量下降。我们旨在阐明这些关联是否独立于潜在的混杂因素。我们还将探讨POD与新发痴呆之间的关联。
本研究将从正在进行的“麻醉脑电图引导以减轻老年综合征”(ENGAGES)研究中招募200名患者。居住在距研究中心≤45英里或术后10 - 16个月计划前往该中心就诊的患者将符合条件。通过混乱评估法测量有POD的患者将与无谵妄的患者进行比较。将比较两组人群认知功能的主要结局以及生活质量和新发痴呆的次要结局。认知将通过A和B连线测验以及斯特鲁普颜色和文字测验进行测量,生活质量通过退伍军人兰德12项健康调查进行评估,新发痴呆通过简易精神状态检查表进行评估。将进行多变量回归分析和Cox比例风险分析。所有结果将以95%置信区间报告,α = 0.05。
该研究已获得圣路易斯华盛顿大学机构审查委员会批准(IRB编号201601099)。传播计划包括科学出版物以及在科学会议上的报告。
NCT02241655。