Zhao Yi, Liu Juan, Ou Mengchan, Hao Xuechao
Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, China.
The Research Units of West China (2018RU012), Chinese Academy of Medical Sciences, West China Hospital, Sichuan University, Chengdu, China.
Front Med (Lausanne). 2022 Apr 25;9:809335. doi: 10.3389/fmed.2022.809335. eCollection 2022.
Postoperative delirium (POD) is a common disorder following surgery, which seriously threatens the quality of patients' life, especially the older people. The multifactorial manner of this syndrome has made it hard to define an ideal method to predict individual risk. Mitochondria play a key role in the process of POD, which include inflammatory on the brain caused by surgeries and aging related neurodegeneration. As BHI (Bioenergetic Health Index) could be calculated in cells isolated from an individual's blood to represent the patient's composite mitochondrial statue, we hypotheses that HBI of monocytes isolated from individual's peripheral blood can predict POD after major non-cardiac surgery in elderly patients.
This is a prospective, observational single-blinded study in a single center. 124 patients aged ≥ 65 years and scheduled for major abdominal surgery (>3 h) under general anesthesia will be enrolled. Preoperative and postoperative delirium will be assessed by trained members using Confusion Assessment Method (CAM). For patients unable to speak in the ICU after the surgery, Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) will be used. All patients will undergo venous blood sampling twice to measure BHI (1-2 tubes, 5 ml/tube): before the surgery and 1 day after surgery in wards. After discharge, patients will be contacted by telephone 30 days after surgery to confirm the incidence of post-discharge complications. The severity of complications will be categorized as mild, moderate, severe or fatal using a modified Clavien-Dindo Classification (CDC) scheme.
The study has been approved by the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University, Sichuan, China (Chairperson Prof Shaolin Deng, No. 2021-502). Study data will be disseminated in manuscripts submitted to peer-reviewed medical journals as well as in abstracts submitted to congresses.
[www.ClinicalTrials.gov], identifier [ChiCTR2100047554].
术后谵妄（POD）是手术后常见的一种病症，严重威胁患者的生活质量，尤其是老年人。该综合征的多因素性质使得难以确定一种理想的方法来预测个体风险。线粒体在POD过程中起关键作用，这包括手术引起的脑部炎症和与衰老相关的神经退行性变。由于生物能量健康指数（BHI）可以从个体血液中分离的细胞中计算得出，以代表患者的综合线粒体状态，我们假设从个体外周血中分离的单核细胞的HBI可以预测老年患者非心脏大手术后的POD。
这是一项在单一中心进行的前瞻性、观察性单盲研究。将招募124名年龄≥65岁、计划在全身麻醉下进行大腹部手术（>3小时）的患者。术前和术后谵妄将由经过培训的人员使用谵妄评估方法（CAM）进行评估。对于术后在重症监护病房（ICU）无法说话的患者，将使用重症监护病房谵妄评估方法（CAM-ICU）。所有患者将接受两次静脉血采样以测量BHI（1-2管，每管5毫升）：手术前和术后第1天在病房进行。出院后，术后30天通过电话联系患者以确认出院后并发症的发生率。并发症的严重程度将使用改良的Clavien-Dindo分类（CDC）方案分为轻度、中度、重度或致命。
该研究已获得中国四川省四川大学华西医院生物医学研究伦理委员会的批准（主席邓少林教授，编号2021-502）。研究数据将在提交给同行评审医学期刊的手稿以及提交给大会的摘要中传播。
