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脑自动调节监测指导体外循环期间平均动脉压目标管理对老年患者术后谵妄的影响:一项嵌套随机临床试验。

Effect of Targeting Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation on Postsurgical Delirium Among Older Patients: A Nested Randomized Clinical Trial.

机构信息

Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.

出版信息

JAMA Surg. 2019 Sep 1;154(9):819-826. doi: 10.1001/jamasurg.2019.1163.

Abstract

IMPORTANCE

Delirium occurs in up to 52% of patients after cardiac surgery and may result from changes in cerebral perfusion. Using intraoperative cerebral autoregulation monitoring to individualize and optimize cerebral perfusion may be a useful strategy to reduce the incidence of delirium after cardiac surgery.

OBJECTIVE

To determine whether targeting mean arterial pressure during cardiopulmonary bypass (CPB) using cerebral autoregulation monitoring reduces the incidence of delirium compared with usual care.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial nested within a larger trial enrolled patients older than 55 years who underwent nonemergency cardiac surgery at a single US academic medical center between October 11, 2012, and May 10, 2016, and had a high risk for neurologic complications. Patients, physicians, and outcome assessors were masked to the assigned intervention. A total of 2764 patients were screened, and 199 were eligible for analysis in this study.

INTERVENTION

In the intervention group, the patient's lower limit of cerebral autoregulation was identified during surgery before CPB. On CPB, the patient's mean arterial pressure was targeted to be greater than that patient's lower limit of autoregulation. In the control group, mean arterial pressure targets were determined according to institutional practice.

MAIN OUTCOMES AND MEASURES

The main outcome was any incidence of delirium on postoperative days 1 through 4, as adjudicated by a consensus expert panel.

RESULTS

Among the 199 participants in this study, mean (SD) age was 70.3 (7.5) years and 150 (75.4%) were male. One hundred sixty-two (81.4%) were white, 26 (13.1%) were black, and 11 (5.5%) were of other race. Of 103 patients randomized to usual care, 94 were analyzed, and of 102 patients randomized to the intervention 105 were analyzed. Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04). The odds of delirium were reduced by 45% in patients randomized to the autoregulation group (odds ratio, 0.55; 95% CI, 0.31-0.97; P = .04).

CONCLUSIONS AND RELEVANCE

The results of this study suggest that optimizing mean arterial pressure to be greater than the individual patient's lower limit of cerebral autoregulation during CPB may reduce the incidence of delirium after cardiac surgery, but further study is needed.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT00981474.

摘要

重要性

心脏手术后,多达 52%的患者会出现谵妄,这可能是由于脑灌注的变化引起的。使用术中脑自动调节监测来个体化和优化脑灌注可能是降低心脏手术后谵妄发生率的一种有用策略。

目的

确定在体外循环 (CPB) 期间使用脑自动调节监测来靶向平均动脉压是否比常规护理降低谵妄的发生率。

设计、地点和参与者:这项随机临床试验嵌套在一项更大的试验中,纳入了 2012 年 10 月 11 日至 2016 年 5 月 10 日期间在美国一家学术医疗中心接受非紧急心脏手术的年龄超过 55 岁的患者,这些患者存在神经并发症的高风险。患者、医生和结果评估者对分配的干预措施均不知情。共有 2764 名患者接受了筛查,其中 199 名符合本研究分析条件。

干预

在干预组中,在 CPB 前手术期间确定患者的脑自动调节下限。在 CPB 期间,将患者的平均动脉压靶向设定为大于该患者的自动调节下限。在对照组中,平均动脉压目标根据机构实践确定。

主要结局和测量指标

主要结局是通过共识专家小组判定的术后第 1 至 4 天任何发生谵妄的情况。

结果

在这项研究的 199 名参与者中,平均(SD)年龄为 70.3(7.5)岁,150 名(75.4%)为男性。162 名(81.4%)为白人,26 名(13.1%)为黑人,11 名(5.5%)为其他种族。在 103 名接受常规护理的患者中,有 94 名进行了分析,在 102 名接受干预的患者中,有 105 名进行了分析。排除 5 名昏迷患者后,常规护理组 91 名患者中有 48 名(53%)发生谵妄,干预组 103 名患者中有 39 名(38%)发生谵妄(P=0.04)。随机分配到自动调节组的患者发生谵妄的可能性降低了 45%(优势比,0.55;95%CI,0.31-0.97;P=0.04)。

结论和相关性

这项研究的结果表明,在 CPB 期间将平均动脉压优化至大于个体患者的脑自动调节下限可能会降低心脏手术后谵妄的发生率,但需要进一步研究。

试验注册

ClinicalTrials.gov 标识符:NCT00981474。

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