脑监测和术后谵妄及结果 (Techno-5)
脑无创监测和预测术后谵妄和结果的验证:一项前瞻性观察研究
研究概览
地位
条件
详细说明
问题概述:心脏手术中的术后谵妄 2002 年,MHI 的手术室开始使用 NIRS 进行大脑监测。 自那段时间以来,研究人员从已发表的病例报告 (n=30)、队列研究 (n=1270)、随机对照试验 (n=313) 和评论文章中描述了我们对 1613 名报告患者的经验。
在大脑去饱和的情况下,研究人员之前描述了一种基于一系列干预措施(例如头部定位、增加血压和吸入氧气等)的算法方法,这些干预措施由病因触发,一次或同时,理想情况下,尽早即当脑 NIRS 值开始下降超过 10% 时。 脑去饱和度校正的成功率超过 95%。
大脑 NIRS 和 pEEG 的使用导致了新的见解,这些见解在单独使用这些技术时并不明显。 例如,在醒来时会观察到 pEEG 活动增加导致的大脑去饱和。 另一方面,与 pEEG 活动减少相关的脑去饱和可能表明脑灌注不足。 2019 年 5 月推出并发布了一种管理大脑 NIRS 和 pEEG 的新算法。
该算法尚未经过验证,可能代表心脏手术患者护理方面的重大进步。 这种监测的潜在作用之一是它能够预测出现的谵妄、术后谵妄和其他终末器官并发症。 最终,早期识别可能导致预防术后并发症,如谵妄。
脑血氧测定和谵妄 16% 到 30% 的老年心血管疾病住院患者会出现谵妄。 谵妄和认知功能障碍在所有医疗机构的住院患者中非常常见,但在外科和重症监护人群中尤其如此,据报道其发生率高达 70%。 心脏手术后谵妄患者的死亡率增加。
DSM-5 将谵妄定义为与注意力缺陷和意识改变相关的急性脑功能障碍。 已经描述了三种类型的谵妄:与嗜睡相关的活动减退,与激动相关的过度活跃以及可以交替出现的两者的组合。 有几个诱发因素,例如术前认知功能障碍。 最近的系统评价确定了以下与谵妄发生相关的因素。 这些因素包括高龄、既往精神疾病、轻度认知障碍和脑血管疾病。 术后谵妄与住院时间延长、术后并发症和死亡率增加有关。
有几份报告将手术人群的大脑 NIRS 测量值降低、精神错乱和术后认知功能障碍联系起来。 脑饱和度降低和谵妄并存的机制可能包括右心功能障碍引起的脑灌注不良和静脉充血。 最近对这些因素进行了探索,并且在 ICU 和手术室中报告了它们与谵妄和术后认知功能障碍的关联。 由于右心功能障碍可能与长期静脉高压有关,这可能导致间质性水肿,从而进一步损害终末器官灌注,例如大脑。 在体外循环 (CPB) 的情况下,这种现象可能会因内皮糖萼的改变而加剧,从而导致毛细血管内皮的通透性增加。 由此产生的间质性水肿被认为是危重液体超负荷患者不良结局的介质。 除了在心脏手术后观察到谵妄的 NIRS 值改变外,还描述了异常的脑电活动。
大脑脑电图监测和谵妄 大脑的电活动可以通过脑电图 (EEG) 进行监测,最近床边的 pEEG 监测器,如 BIS(美敦力,美国)或 Sedline(Masimo Irvine CA)允许床边测量额叶电活动。 谵妄与 EEG 变化有关,通常是 EEG 活动的整体减慢。 在有或没有谵妄的老年人中观察到脑电图存在显着差异。 与其他 EEG 波相关的 alpha、theta 和 delta 波功率和 θ 比率在有或没有谵妄的患者中是不同的。 此外,导致“爆发抑制”的 EEG 活动显着减少与谵妄出现、住院时间延长和死亡率有关。 研究和荟萃分析报告了有争议的结果,这些研究和荟萃分析着眼于纠正这些因素并改善结果的干预措施。 然而,这些观察从未将从额叶脑电图获得的信息与脑血氧测定相结合。 最近来自比利时的一项前瞻性研究报告了与术后谵妄的关联以及结合使用大脑 NIRS 和 pEEG 获得的信息。
先前关于谵妄和脑血氧测定以及脑电图监测的工作 2011 年,研究人员报告了我们在 61 名接受非体外循环心脏旁路手术的患者中使用 NIRS 作为术后认知功能障碍预测指标的首次经验。 2016 年,对 30 名心脏手术后出现谵妄的成人进行了一项观察性研究。 在谵妄发作后的第一天,平均血氧饱和度值从(平均值±标准差)66.4±6.7 下降到 50.8±6.8,并且在 3 天内谵妄吸收的患者中增加。 使用边际模型和线性混合模型分析了血氧测定、谵妄诊断和严重程度之间的关系。 脑氧饱和度与谵妄诊断 (p≤.0001) 和严重程度 (p≤.0001) 相关。 在该研究中,谵妄患者的体氧饱和度值正常。
2017 年的第二项研究是一项病例对照回顾性研究,共纳入 346 名患者,其中 39 名(11%)、104 名(30%)和 142 名(41%)患者在 24、48 和 72 小时出现谵妄分别到达 ICU 后。 累积液体平衡与谵妄发生相关(OR 1.20, 95% CI: 1.066-1.355, p=.003)。 神经系统疾病史、听力和视力障碍、手术类型、围手术期脑血氧饱和度、CPB 前平均肺动脉压和 CPB 后平均动脉压也导致模型出现谵妄。
在第三项研究中,报告了一个回顾性和前瞻性队列,共包括 382 名患者。 在 ICU 的常规护理期间由主治医师接受门静脉脉冲波多普勒检查的成年患者被纳入回顾性队列 (n=237)。 对于前瞻性队列 (n=145),患者在手术前一天和手术后三天每天进行认知和超声心动图评估。 前瞻性队列中的护理人员对谵妄进行了独立评估。 在回顾性队列中发现谵妄与门静脉搏动(右心衰竭的标志)之间存在关联(OR:2.69 CI:1.47-4.90 p=0.001)。 在前瞻性队列中,门静脉搏动的存在与研究人员评估的认知功能障碍和扑翼样震颤的发展之间存在显着关联(OR:2.10 CI:1.25-3.53 p=0.005 和 OR:5.19 [CI:2.27; 11.88] p<0.001) 但也证实了护理人员检测到与谵妄的关联(HR:2.63 CI:1.13-6.11 p=0.025)。 更高的 NT-pro-BNP 测量值(OR:4.03 [可信度:1.78-9.15] p=0.001) 和大脑去饱和 (OR:2.54 [CI:1.12-5.76] p=0.03) 与认知功能障碍有关。 在这第三项研究中,每天结合 NIRS 值获取基线每日 pEEG。 然而,在谵妄和初步波形分析之间没有观察到关联。
总之,这些研究支持通过脑血氧测定法测量的脑去饱和发作与谵妄的发生之间存在关联。 右心室功能障碍导致的静脉脑充血导致门静脉高压症和可能通过心肠综合征释放细胞因子似乎是一种潜在的机制。 正如其他作者所支持的那样,大脑 NIRS 值降低可能继发于静脉压升高、液体超负荷,而后者会导致一种充血性谵妄。 它也可能反映大脑代谢增加,例如当患者在心脏手术后从全身麻醉中苏醒时可以观察到。 然而,在这些研究中,仅获得了单个脑 NIRS 和 pEEG 值。 在手术室和 ICU 中,未对两种模式与双侧脑 NIRS 的结合使用进行前瞻性研究。 目前,尚不清楚这些监测器获得的信息在出现谵妄发作的患者与未出现任何术后谵妄发作的患者中是否不同。
研究类型
注册 (实际的)
联系人和位置
学习地点
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Quebec
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Montreal、Quebec、加拿大、H1T 1C8
- Montreal Heart Institute
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
取样方法
研究人群
描述
纳入标准:
- 接受 CPB 或非体外循环 CABG 心脏手术的 18 岁及以上男性或女性患者
排除标准:
- 术前处于危急状态的患者定义为以下任何一种情况:血管升压药需求、机械循环支持、透析、机械通气、需要复苏的心脏骤停、猝死中止、术前心脏按摩、术前主动脉内球囊泵。
- 患者在当前住院期间手术前任何时间被诊断为谵妄
- 紧急手术
- 深低温停循环手术
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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神经系统事件发生率
大体时间:72小时
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事件将根据近红外光谱测量的氧饱和度变化和患者状态指数、突发抑制比和光谱边缘频率评估的 pEEG 活动变化进行分类。 事件将根据以下分类进行分类:
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72小时
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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认知功能障碍率
大体时间:72小时
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认知功能障碍将被定义为谵妄指数评分≥1
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72小时
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谵妄率
大体时间:72小时
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谵妄将被定义为重症监护谵妄筛查清单 (ICDSC):得分≥4
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72小时
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持续性器官功能障碍的持续时间
大体时间:最多 28 天或直到出院
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持续性器官功能障碍定义为以下一项或多项:机械通气;血管加压药治疗(持续需要血管加压药,例如去甲肾上腺素、肾上腺素、血管加压素、多巴胺 >5 μg/kg/min 或去氧肾上腺素 >50 μg/min);机械循环支持(持续需要机械设备,如 ECMO 或 IABP);新的持续性肾脏替代疗法或新的间歇性血液透析(从第一次透析到最后一次透析)。 因此,TPOD 代表患者在心脏手术后需要有创生命支持的时间。 2. ICU 住院时间(小时) 3. 住院时间(天) |
最多 28 天或直到出院
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住院期间全因死亡率
大体时间:最多 30 天或直到出院
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因任何原因死亡
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最多 30 天或直到出院
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急性肾损伤发生率
大体时间:最多 30 天或直到出院
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根据 KDIGO 血清肌酐标准定义:48 小时内增加≥27 umol/L 或增加≥50%
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最多 30 天或直到出院
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大出血率
大体时间:最多 30 天或直到出院
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由出血学术研究联盟定义为以下之一: 围手术期48h内颅内出血 ii. 胸骨切开术闭合后再次手术以控制出血 iii. 48 小时内输注≥5 个单位的浓缩红细胞全血 iv. 24小时内胸管排量≥2L。 |
最多 30 天或直到出院
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再次手术干预率
大体时间:最多 30 天或直到出院
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因任何原因在同一住院期间进行第二次手术
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最多 30 天或直到出院
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冲程率
大体时间:最多 30 天或直到出院
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持续超过 72 小时的中枢神经功能缺损
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最多 30 天或直到出院
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机械通气时间
大体时间:最多 30 天或直到出院
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插管患者呼吸器机械支持的持续时间
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最多 30 天或直到出院
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合作者和调查者
调查人员
- 首席研究员:Andre Y Denault, MD, PhD、Montreal Heart Institute
出版物和有用的链接
一般刊物
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- Couture EJ, Deschamps A, Denault AY. Patient management algorithm combining processed electroencephalographic monitoring with cerebral and somatic near-infrared spectroscopy: a case series. Can J Anaesth. 2019 May;66(5):532-539. doi: 10.1007/s12630-019-01305-y. Epub 2019 Feb 1.
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