Abstract：
BACKGROUND: Whether the optimization of cerebral oxygenation based on regional cerebral oxygen saturation (rSO2) monitoring reduces the occurrence of cerebral ischemic lesions is unknown.
METHODS: This multicenter, randomized, controlled trial recruited adults admitted for scheduled carotid endarterectomy. Patients were randomized between the standard of care or optimization of cerebral oxygenation based on rSO2 monitoring using near-infrared spectroscopy. In the intervention group, in case of a decrease in rSO2 in the intervention, the following treatments were sequentially recommended: (1) increasing oxygenotherapy, (2) reducing the tidal volume, (3) legs up-raising, (4) performing a fluid challenge and (5) initiating vasopressor support. The primary endpoint was the number of new cerebral ischemic lesions detected using magnetic resonance imaging pre- and postoperatively. Secondary endpoints included new neurological deficits and mortality on day 120 after surgery.
RESULTS: Among the 879 patients who were randomized, 665 (75.7%) were men. There was no statistically significant difference between groups for the mean number of new cerebral ischemic lesions per patient up to 3 days after surgery: 0.35 (±1.05) in the standard group vs. 0.58 (±2.83), in the NIRS group; mean difference, 0.23 [95% CI, -0.06 to 0.52]; estimate, 0.22 [95% CI, -0.06 to 0.50]. New neurological deficits up to day 120 after hospital discharge were not different between the groups: 15 (3,39%) in the standard group vs. 42 (5,49%) in the NIRS group; absolute difference, 2,10 [95% CI, -0,62 to 4,82]. There was no significant difference between groups for the median [IQR] hospital length of stay: 4.0 [4.0-6.0] in the standard group vs. 5.0 [4.0-6.0] in the NIRS group; mean difference, -0.11 [95% CI, -0.65 to 0.44]. The mortality rate on day 120 was not different between the standard group (0.68%) vs. the NIRS group (0.92%); absolute difference = 0.24% [95% CI, -0.94 to 1.41].
CONCLUSIONS: Among patients undergoing carotid endarterectomy, optimization of cerebral oxygenation based on rSO2 did not reduce the occurrence of cerebral ischemic lesions postoperatively compared with controlled hypertensive therapy.
BACKGROUND: ClinicalTrials.gov identifier: NCT01415648.
METHODS: This multicenter, randomized, controlled trial recruited adults admitted for scheduled carotid endarterectomy. Patients were randomized between the standard of care or optimization of cerebral oxygenation based on rSO2 monitoring using near-infrared spectroscopy. In the intervention group, in case of a decrease in rSO2 in the intervention, the following treatments were sequentially recommended: (1) increasing oxygenotherapy, (2) reducing the tidal volume, (3) legs up-raising, (4) performing a fluid challenge and (5) initiating vasopressor support. The primary endpoint was the number of new cerebral ischemic lesions detected using magnetic resonance imaging pre- and postoperatively. Secondary endpoints included new neurological deficits and mortality on day 120 after surgery.
RESULTS: Among the 879 patients who were randomized, 665 (75.7%) were men. There was no statistically significant difference between groups for the mean number of new cerebral ischemic lesions per patient up to 3 days after surgery: 0.35 (±1.05) in the standard group vs. 0.58 (±2.83), in the NIRS group; mean difference, 0.23 [95% CI, -0.06 to 0.52]; estimate, 0.22 [95% CI, -0.06 to 0.50]. New neurological deficits up to day 120 after hospital discharge were not different between the groups: 15 (3,39%) in the standard group vs. 42 (5,49%) in the NIRS group; absolute difference, 2,10 [95% CI, -0,62 to 4,82]. There was no significant difference between groups for the median [IQR] hospital length of stay: 4.0 [4.0-6.0] in the standard group vs. 5.0 [4.0-6.0] in the NIRS group; mean difference, -0.11 [95% CI, -0.65 to 0.44]. The mortality rate on day 120 was not different between the standard group (0.68%) vs. the NIRS group (0.92%); absolute difference = 0.24% [95% CI, -0.94 to 1.41].
CONCLUSIONS: Among patients undergoing carotid endarterectomy, optimization of cerebral oxygenation based on rSO2 did not reduce the occurrence of cerebral ischemic lesions postoperatively compared with controlled hypertensive therapy.
BACKGROUND: ClinicalTrials.gov identifier: NCT01415648.
摘要：
背景：基于局部脑氧饱和度（rSO2）监测的脑氧合优化是否可以减少脑缺血病变的发生未知。
方法：这个多中心，随机化，对照试验招募了接受预定颈动脉内膜切除术的成人.根据使用近红外光谱的rSO2监测，患者在护理标准或优化脑氧合之间进行随机分配。在干预组中，在干预中rSO2减少的情况下，依次推荐以下治疗：（1）增加氧疗，(2)减少潮气量,(3)抬腿,（4）进行液体攻击和（5）启动血管加压药支持。主要终点是术前和术后使用磁共振成像检测到的新的脑缺血病变的数量。次要终点包括手术后第120天的新的神经功能缺损和死亡率。
结果：在随机分组的879名患者中，665人（75.7%）为男性。手术后3天，每位患者的平均新脑缺血病变数量在两组之间没有统计学上的显着差异：标准组0.35（±1.05）与0.58(±2.83),在NIRS组中；平均差，0.23[95%CI，-0.06至0.52]；估计值，0.22[95%CI，-0.06至0.50]。出院后直到第120天的新神经功能缺损在两组之间没有差异：标准组的15（3,39％）与NIRS组42例(5,49%)；绝对差异，2,10[95%CI，-0.62至4,82]。标准组的中位[IQR]住院时间：4.0[4.0至6.0]与NIRS组的5.0[4.0-6.0]之间没有显着差异；平均差异，-0.11[95%CI，-0.65至0.44]。第120天的死亡率在标准组之间没有差异（0.68％）与NIRS组（0.92%）；绝对差异=0.24%[95%CI，-0.94至1.41]。
结论：在接受颈动脉内膜切除术的患者中，与控制性高血压治疗相比，基于rSO2的脑氧合优化并没有减少术后脑缺血病变的发生。
背景：ClinicalTrials.gov标识符：NCT01415648。
方法：这个多中心，随机化，对照试验招募了接受预定颈动脉内膜切除术的成人.根据使用近红外光谱的rSO2监测，患者在护理标准或优化脑氧合之间进行随机分配。在干预组中，在干预中rSO2减少的情况下，依次推荐以下治疗：（1）增加氧疗，(2)减少潮气量,(3)抬腿,（4）进行液体攻击和（5）启动血管加压药支持。主要终点是术前和术后使用磁共振成像检测到的新的脑缺血病变的数量。次要终点包括手术后第120天的新的神经功能缺损和死亡率。
结果：在随机分组的879名患者中，665人（75.7%）为男性。手术后3天，每位患者的平均新脑缺血病变数量在两组之间没有统计学上的显着差异：标准组0.35（±1.05）与0.58(±2.83),在NIRS组中；平均差，0.23[95%CI，-0.06至0.52]；估计值，0.22[95%CI，-0.06至0.50]。出院后直到第120天的新神经功能缺损在两组之间没有差异：标准组的15（3,39％）与NIRS组42例(5,49%)；绝对差异，2,10[95%CI，-0.62至4,82]。标准组的中位[IQR]住院时间：4.0[4.0至6.0]与NIRS组的5.0[4.0-6.0]之间没有显着差异；平均差异，-0.11[95%CI，-0.65至0.44]。第120天的死亡率在标准组之间没有差异（0.68％）与NIRS组（0.92%）；绝对差异=0.24%[95%CI，-0.94至1.41]。
结论：在接受颈动脉内膜切除术的患者中，与控制性高血压治疗相比，基于rSO2的脑氧合优化并没有减少术后脑缺血病变的发生。
背景：ClinicalTrials.gov标识符：NCT01415648。
