■常压高氧(NBO)在急性缺血性中风中具有神经保护作用。因此,我们旨在确定最佳NBO治疗时间与血管内治疗相结合.
■这是一个单中心,随机对照,开放标签,盲法终点剂量递增临床试验.在天津环湖医院有血管内治疗指征的急性缺血性脑卒中患者,根据NBO治疗时间随机分为4组(1:1比例):(1)对照组(1L/min吸氧4小时);(2)NBO-2h组(10L/min持续2小时);(3)NBO-4h组(10L/min持续4小时);(4)NBO-6h主要结果是使用意向治疗分析模型随机分组后72小时的脑梗死体积。主要安全性结果是90天死亡率。
■在2022年6月至2023年9月之间,将100名患者随机分配到以下组中:对照组(n=25),NBO-2h组(n=25),NBO-4h组(n=25),和NBO-6h组(n=25)。72小时脑梗死体积为39.4±34.3mL,30.6±30.1mL,19.7±15.4mL,和22.6±22.4毫升,分别为(P=0.013)。NBO-4h和NBO-6h组与对照组相比均有统计学差异(调整后P值分别为0.011和0.027)。与对照组相比,NBO-4h和NBO-6h组在24小时的美国国立卫生研究院卒中量表评分均有显著性差异(P<0.05),72小时,7天,以及美国国立卫生研究院卒中量表评分从基线到24小时的变化。此外,在90天死亡率方面,四组之间没有显着差异,症状性颅内出血,早期神经退化,或严重不良事件。
■NBO治疗的有效性与氧气给药时间相关。在接受血管内治疗的急性缺血性卒中患者中,发现4小时和6小时的NBO治疗更有效。需要更大规模的多中心研究来验证这些发现。
■URL:https://www。clinicaltrials.gov;唯一标识符:NCT05404373。
UNASSIGNED: Normobaric
hyperoxia (NBO) has neuroprotective effects in acute ischemic stroke. Thus, we aimed to identify the optimal NBO treatment duration combined with endovascular treatment.
UNASSIGNED: This is a single-center, randomized controlled, open-label, blinded-end point dose-escalation clinical
trial. Patients with acute ischemic stroke who had an indication for endovascular treatment at Tianjin Huanhu Hospital were randomly assigned to 4 groups (1:1 ratio) based on NBO therapy duration: (1) control group (1 L/min oxygen for 4 hours); (2) NBO-2h group (10 L/min for 2 hours); (3) NBO-4h group (10 L/min for 4 hours); and (4) NBO-6h group (10 L/min for 6 hours). The primary outcome was cerebral infarction volume at 72 hours after randomization using an intention-to-treat analysis model. The primary safety outcome was the 90-day mortality rate.
UNASSIGNED: Between June 2022 and September 2023, 100 patients were randomly assigned to the following groups: control group (n=25), NBO-2h group (n=25), NBO-4h group (n=25), and NBO-6h group (n=25). The 72-hour cerebral infarct volumes were 39.4±34.3 mL, 30.6±30.1 mL, 19.7±15.4 mL, and 22.6±22.4 mL, respectively (P=0.013). The NBO-4h and NBO-6h groups both showed statistically significant differences (adjusted P values: 0.011 and 0.027, respectively) compared with the control group. Compared with the control group, both the NBO-4h and NBO-6h groups showed significant differences (P<0.05) in the National Institutes of Health Stroke Scale scores at 24 hours, 72 hours, and 7 days, as well as in the change of the National Institutes of Health Stroke Scale scores from baseline to 24 hours. Additionally, there were no significant differences among the 4 groups in terms of 90-day mortality rate, symptomatic intracranial hemorrhage, early neurological deterioration, or severe adverse events.
UNASSIGNED: The effectiveness of NBO therapy was associated with oxygen administration duration. Among patients with acute ischemic stroke who underwent endovascular treatment, NBO therapy for 4 and 6 hours was found to be more effective. Larger-scale multicenter studies are needed to validate these findings.
UNASSIGNED: URL: https://www.clinicaltrials.gov; Unique identifier: NCT05404373.