天津大学郭志刚研究小组报道了非体外循环冠状动脉旁路移植术(Bottomline CS)中组织氧合和血流动力学监测指导下的护理。相关论文于2025年3月24日发表于国际顶尖学术期刊《英国医学杂志》上。
目的:评估近红外光谱测定组织氧饱和度和血流动力学监测指导下的围手术期管理是否能减少非体外循环冠状动脉搭桥术术后并发症。
设计:评估者盲法、单中心、随机对照试验(Bottomline-CS试验)。
设置:中国三级教学医院。
参与者:60岁及以上择期行非体外循环冠状动脉旁路移植术的患者1960例。
干预措施:所有患者均进行多部位组织氧饱和度监测(双侧前额和单侧前臂肱桡肌)和血流动力学监测。两组均接受常规护理,包括动脉血压、中心静脉压、心电图和经食管超声心动图。指导护理旨在将组织氧合维持在术前24-48小时基线值以上或以下10%的范围内,从麻醉开始到拔管或术后24小时。常规护理组隐匿组织血氧仪和血流动力学数据,常规护理。
主要结果测量:主要终点是术后30天并发症的复合发生率,包括脑、心、呼吸、肾、感染和死亡并发症。次要结局包括复合结局的个别组成部分、新发房颤和住院时间。
结果:在随机分配的1960例患者中,分析了967例引导式护理患者和974例常规护理患者的数据。麻醉期间,在引导护理下,在正负10%基线范围外组织氧饱和度测量曲线下的面积明显小于常规护理:左前额32.4 vs 57.6 (×min, P<0.001),右前额37.9 vs 62.6 (P<0.001),前臂14.8 vs 44.7 (P<0.001)。指导护理组457/967例(47.3%)患者和常规护理组466/974例(47.8%)患者出现主要复合结局(未调整风险比0.99(95%可信区间0.90 ~ 1.08),P=0.83)。各组间次要结局无显著差异。观察差异最大的是肺炎的发生率,指导护理组的肺炎发生率(88/967,9.1%)低于常规护理组(121/974,12.4%),经多重比较调整后差异无统计学意义。
研究结果表明,与常规护理相比,使用多位点近红外光谱和血流动力学监测的指导护理有效地将组织氧合维持在基线水平附近。然而,没有明确的证据表明该入路降低了主要术后并发症的发生率。这些发现不支持常规使用近红外光谱和血流动力学监测来维持非体外循环冠状动脉旁路移植术期间的组织氧合。
附:英文原文
Title: Care guided by tissue oxygenation and haemodynamic monitoring in off-pump coronary artery bypass grafting (Bottomline-CS): assessor blind, single centre, randomised controlled trial
Author: Jiange Han, Wenqian Zhai, Zhenhua Wu, Zhao Zhang, Tao Wang, Min Ren, Ziyue Liu, Daniel I Sessler, Zhigang Guo, Lingzhong Meng, the Bottomline-CS investigation group
Issue&Volume: 2025/03/24
Abstract: Objective
To assess whether perioperative management guided by near-infrared spectroscopy to determine tissue oxygen saturation and haemodynamic monitoring reduces postoperative complications after off-pump coronary artery bypass grafting.
Design:Assessor blinded, single centre, randomised controlled trial (Bottomline-CS trial).
Setting:A tertiary teaching hospital in China.
Participants:1960 patients aged 60 years or older who were scheduled for elective off-pump coronary artery bypass grafting.
Interventions:All patients had multisite monitoring of tissue oxygen saturation (bilateral forehead and unilateral forearm brachioradialis) and haemodynamic monitoring. Both groups received usual care, including arterial blood pressure, central venous pressure, electrocardiography, and transoesophageal echocardiography when indicated. Guided care aimed to maintain tissue oxygenation within 10% above or below preoperative baseline values, established 24-48 hours before surgery, from the start of anaesthesia until extubation or for up to 24 hours postoperatively. In the usual care group, tissue oximetry and haemodynamic data were concealed, and care was routine.
Main outcome measures:The primary outcome was the incidence of a composite of 30 day postoperative complications, which were cerebral, cardiac, respiratory, renal, infectious, and mortality complications. Secondary outcomes included the individual components of the composite outcome, new-onset atrial fibrillation, and hospital length of stay.
Results:Of 1960 patients randomly assigned, data from 967 guided care and 974 usual care patients were analysed. During anaesthesia, the area under the curve for tissue oxygen saturation measurements outside the plus and minus 10% baseline range was significantly smaller with guided care than only usual care: left forehead 32.4 versus 57.6 (%×min, P<0.001), right forehead 37.9 versus 62.6 (P<0.001), and forearm 14.8 versus 44.7 (P<0.001). The primary composite outcome occurred in 457/967 (47.3%) patients in the guided care group and 466/974 (47.8%) patients in the usual care group (unadjusted risk ratio 0.99 (95% confidence interval 0.90 to 1.08), P=0.83). No secondary outcomes differed significantly between groups. The largest observed difference was in incidence of pneumonia, which was less frequent in the guided care group (88/967, 9.1%) than in the usual care group (121/974, 12.4%) and not statistically significant after adjusting for multiple comparisons.
Conclusions:Guided care by use of multisite near-infrared spectroscopy and haemodynamic monitoring effectively maintained tissue oxygenation near baseline levels compared with usual care. However, no clear evidence was noted that this approach reduced the incidence of major postoperative complications. These findings do not support the routine use of near-infrared spectroscopy and haemodynamic monitoring to maintain tissue oxygenation during off-pump coronary artery bypass grafting.
DOI: 10.1136/bmj-2024-082104
Source: https://www.bmj.com/content/388/bmj-2024-082104
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