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随机临床试验近红外光谱术用于心脏手术期间脑组织氧合的个体化优化。

Randomized trial of near-infrared spectroscopy for personalized optimization of cerebral tissue oxygenation during cardiac surgery.

机构信息

Clinical Trials and Evaluation Unit, School of Clinical Sciences, University of Bristol, Bristol Royal Infirmary, Bristol BS2?8HW, UK.

Bristol Heart Institute and National Institute for Health Research Bristol Biomedical Research Unit in Cardiovascular Medicine, University Hospitals Bristol NHS Foundation Trust, Bristol Royal Infirmary, Bristol BS2?8HW, UK.

出版信息

Br J Anaesth. 2017 Sep 1;119(3):384-393. doi: 10.1093/bja/aex182.

DOI:10.1093/bja/aex182
PMID:28969313
Abstract

BACKGROUND

We assessed whether a near-infrared spectroscopy (NIRS)-based algorithm for the personalized optimization of cerebral oxygenation during cardiopulmonary bypass combined with a restrictive red cell transfusion threshold would reduce perioperative injury to the brain, heart, and kidneys.

METHODS

In a randomized controlled trial, participants in three UK centres were randomized with concealed allocation to a NIRS (INVOS 5100; Medtronic Inc., Minneapolis, MN, USA)-based 'patient-specific' algorithm that included a restrictive red cell transfusion threshold (haematocrit 18%) or to a 'generic' non-NIRS-based algorithm (standard care). The NIRS algorithm aimed to maintain cerebral oxygenation at an absolute value of > 50% or at > 70% of baseline values. The primary outcome for the trial was cognitive function measured up to 3 months postsurgery.

RESULTS

The analysis population comprised eligible randomized patients who underwent valve or combined valve surgery and coronary artery bypass grafts using cardiopulmonary bypass between December 2009 and January 2014 ( n =98 patient-specific algorithm; n =106 generic algorithm). There was no difference between the groups for the three core cognitive domains (attention, verbal memory, and motor coordination) or for the non-core domains psychomotor speed and visuo-spatial skills. The NIRS group had higher scores for verbal fluency; mean difference 3.73 (95% confidence interval 1.50, 5.96). Red cell transfusions, biomarkers of brain, kidney, and myocardial injury, adverse events, and health-care costs were similar between the groups.

CONCLUSIONS

These results do not support the use of NIRS-based algorithms for the personalized optimization of cerebral oxygenation in adult cardiac surgery.

CLINICAL TRIAL REGISTRATION

http://www.controlled-trials.com , ISRCTN 23557269.

摘要

背景

我们评估了心肺转流过程中基于近红外光谱(NIRS)的脑氧个体化优化算法联合限制性红细胞输血阈值是否会减少围手术期脑、心和肾的损伤。

方法

在一项随机对照试验中,三个英国中心的参与者被随机分为接受基于 NIRS(INVOS 5100;美敦力公司,明尼苏达州明尼阿波利斯)的“个体化”算法的组(包括限制性红细胞输血阈值[血细胞比容 18%])和接受基于非 NIRS 的“通用”算法的组(标准护理)。NIRS 算法旨在将脑氧合维持在绝对值>50%或>基线值的 70%。该试验的主要结局是术后 3 个月时的认知功能测量。

结果

分析人群包括在 2009 年 12 月至 2014 年 1 月期间接受心肺转流的瓣膜或联合瓣膜手术和冠状动脉旁路移植术的合格随机患者(NIRS 组:98 例患者;通用算法组:106 例患者)。两组在三个核心认知域(注意力、言语记忆和运动协调)或非核心域精神运动速度和视觉空间技能方面没有差异。NIRS 组的言语流畅性评分较高;平均差异 3.73(95%置信区间 1.50,5.96)。红细胞输注、脑、肾和心肌损伤的生物标志物、不良事件和医疗保健成本在两组之间相似。

结论

这些结果不支持在成人心脏手术中使用基于 NIRS 的算法来个体化优化脑氧合。

临床试验注册

http://www.controlled-trials.com ,ISRCTN23557269。

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