Department of Anesthesiology, Shandong Institute of Anesthesia and Respiratory Critical Medicine, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan, China.
Department of Anesthesiology, Shandong First Medical University, Jinan, China.
PLoS One. 2024 Mar 6;19(3):e0295500. doi: 10.1371/journal.pone.0295500. eCollection 2024.
To Frailty is associated with postoperative delirium (POD) but is rarely assessed in patients undergoing noncardiac surgery. In this study, the correlation between preoperative frailty and POD, one-year mortality will be investigated in noncardiac Chinese geriatric surgery patients.
This study is a prospective, observational, cohort study conducted at a single center with Chinese geriatric patients. Patients who undergo noncardiac surgery and are older than 70 years will be included. A total of 536 noncardiac surgery patients will be recruited from the First Affiliated Hospital of Shandong First Medical University for this study. The Barthel Index (BI) rating will be used to assess the patient's ability to carry out everyday activities on the 1st preoperative day. The modified frailty index (mFI) will be used to assess frailty. Patients in the nonfrailty group will have an mFI < 0.21, and patients in the frailty group will have an mFI ≥ 0.21. The primary outcome is the incidence of POD. Three-Minute Diagnostic Interview for CAM-defined Delirium (3D-CAM) will be conducted twice daily during the 1st-7th postoperative days, or just before discharge. The secondary outcomes will include one-year mortality, in-hospital cardiopulmonary events, infections, acute renal injury, and cerebrovascular events.
This study will clarify the correlation of preoperative frailty with POD and one-year all-cause mortality in Chinese geriatric patients undergoing noncardiac surgery. Can preoperative frailty predict POD or one-year mortality? In the face of China's serious aging social problems, this result may have important clinical value for the surgical treatment of geriatric patients.
This protocol has been registered with ClinicalTrials. Gov on 12 January 2022 (https://clinicaltrials.gov/ct2/show/NCT05189678).
衰弱与术后谵妄(POD)有关,但在非心脏手术患者中很少评估。在这项研究中,将研究术前衰弱与 POD 和一年死亡率之间的相关性,研究对象为中国老年非心脏手术患者。
这是一项在单一中心进行的前瞻性、观察性队列研究,纳入中国老年患者。将纳入接受非心脏手术且年龄大于 70 岁的患者。本研究将从山东第一医科大学第一附属医院招募 536 名非心脏手术患者。第 1 个术前日将使用巴氏指数(BI)评分评估患者进行日常活动的能力。将使用改良衰弱指数(mFI)评估衰弱。非衰弱组患者的 mFI<0.21,衰弱组患者的 mFI≥0.21。主要结局是 POD 的发生率。术后第 1-7 天,每天将进行两次 3 分钟诊断性访谈用于 CAM 定义的谵妄(3D-CAM),或在出院前进行。次要结局包括 1 年死亡率、院内心肺事件、感染、急性肾损伤和脑血管事件。
本研究将阐明中国老年非心脏手术患者术前衰弱与 POD 和 1 年全因死亡率的相关性。术前衰弱能否预测 POD 或 1 年死亡率?面对中国严重的老龄化社会问题,这一结果可能对老年患者的手术治疗具有重要的临床价值。
该方案于 2022 年 1 月 12 日在 ClinicalTrials.gov 上注册(https://clinicaltrials.gov/ct2/show/NCT05189678)。