Care guided by tissue oxygenation and haemodynamic monitoring in off-pump coronary artery bypass grafting (Bottomline-CS): assessor blind, single centre, randomised controlled trial.

Methods

Assessor blinded, single centre, randomised controlled trial(Bottomline-CS trial).

评估者盲法、单中心、随机对照试验（Bottomline-CS试验）。

A tertiary teaching hospital in China.

中国的一家三级教学医院。

1960 patients aged 60 years or older who were scheduled for elective off-pump coronary artery bypass grafting.

1960名年龄在60岁或以上的患者，计划进行择期非体外循环冠状动脉旁路移植术。

All patients had multisite monitoring of tissue oxygen saturation (bilateral forehead and unilateral forearm brachioradialis) and haemodynamic monitoring.

所有患者均进行了多部位组织氧饱和度监测（双侧前额和单侧前臂桡侧）以及血流动力学监测。

Both groups received usual care, including arterial blood pressure, central venous pressure, electrocardiography, and transoesophageal echocardiography when indicated.

两组患者均接受了常规护理，包括动脉血压、中心静脉压、心电图以及在指征时进行经食管超声心动图。

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.

指导性护理旨在维持组织氧合在术前基线值的±10%范围内，该基线值在手术前24-48小时确定，从麻醉开始直到拔管或术后最多24小时。

In the usual care group, tissue oximetry and haemodynamic data were concealed, and care was routine.

在常规护理组中，组织氧合监测和血流动力学数据被隐藏，护理为常规进行。

The primary outcome was the incidenceof a composite of 30 day postoperative complications, which were cerebral, cardiac, respiratory, renal, infectious, and mortality complications.

主要结果是30天术后并发症的发生率，这些并发症包括脑部、心脏、呼吸、肾脏、感染和死亡并发症。

Secondary outcomes included the individual components of the composite outcome, new-onset atrial fibrillation, and hospital length of stay.

次要结果包括复合结果的各个组成部分、新发房颤以及住院时长。

Results

Of 1960 patients randomly assigned, data from 967 guided care and 974 usual care patients were analysed.

在随机分配的1960名患者中，分析了967名指导护理和974名常规护理患者的资料。

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).

在麻醉过程中，指导护理组的组织氧饱和度测量值在基线范围±10%之外的曲线下面积显著小于仅常规护理组：左侧额头32.4对57.6（%×分钟，P<0.001），右侧额头37.9对62.6（P<0.001），前臂14.8对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 interval0.90 to 1.08), P=0.83).

主要复合结果在指导护理组的967名患者中有457名（47.3%）发生，在常规护理组的974名患者中有466名（47.8%）发生（未调整的风险比为0.99（95%置信区间0.90至1.08），P=0.83）。

No secondary outcomes differed significantly between groups.

两组之间次要结果没有显著差异。

The largest observed difference was in incidenceof 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.

观察到的最大差异在于肺炎的发生率，指导护理组（88/967，9.1%）比常规护理组（121/974，12.4%）的发生率低，但在调整多重比较后，差异不具有统计学意义。

Conclusions

Guided care by use of multisite near-infrared spectroscopy and haemodynamic monitoring effectively maintained tissue oxygenation near baseline levels compared with usual care.

通过使用多部位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接近基线水平，与常规护理相比。

However, no clear evidence was noted that this approach reduced the incidenceof major postoperative complications.

然而，没有明显证据表明这种方法能减少主要术后并发症的发生率。

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.

这些发现不支持在非体外循环冠状动脉旁路移植术期间常规使用近红外光谱和血流动力学监测来维持组织氧合。

trial_registration

ClinicalTrials.gov NCT04896736.

ClinicalTrials.gov NCT04896736。