目的:比较骨内和静脉内血管通路治疗成人院外心脏骤停患者的有效性。
方法:集群随机对照试验。
方法:在院外心脏骤停患者复苏期间,VICTOR(静脉注射与骨内注射相比)试验涉及急诊医疗服务机构以及台北市所有四个高级生命支持救护队,台湾。注册期为2020年7月6日至2023年6月30日,由于covid-19大流行,在2021年5月20日至2021年7月31日期间暂时中止。
方法:成人(20-80岁)非创伤性院外心脏骤停患者。
方法:每两周随机分组,由四个参与的高级生命支持救护团队组成,被分配插入静脉或骨内通道。
方法:主要结局是生存至出院。次要结果包括自发循环的恢复,自发循环持续恢复(≥2小时),以及出院时神经系统预后良好(脑功能分类评分≤2)的生存率。
结果:在1771名入选患者中,1732例(骨内组741例,静脉注射组991例)纳入主要分析(中位年龄65.0岁;男性1234例(71.2%))。在骨内组,79例(10.7%)患者存活出院,与静脉组102例(10.3%)患者相比(比值比1.04,95%置信区间0.76至1.42;P=0.81)。对于院前自发循环的恢复,骨内与静脉入路的比值比为1.23(0.89至1.69;P=0.21),0.92(0.75至1.13;P=0.44)用于自发循环的持续恢复,和1.17(0.82至1.66;P=0.39)存活,神经系统预后良好。
结论:在非创伤性院外心脏骤停的成年人中,最初尝试通过骨内途径建立血管通路与静脉通路相比,在存活出院的患者比例方面没有导致不同的结果。院前自发循环恢复,自发循环的持续恢复,和良好的神经系统结果。
背景:NCT04135547ClinicalTrials.govNCT04135547。
To compare the effectiveness of intraosseous versus intravenous vascular access in the treatment of adult patients with out-of-hospital cardiac arrest.
Cluster randomised controlled trial.
The VICTOR (Venous Injection Compared To intraOsseous injection during resuscitation of patients with out-of-hospital cardiac arrest) trial involved emergency medical service agencies with all four advanced life support ambulance teams in Taipei City, Taiwan. The enrolment period spanned 6 July 2020 to 30 June 2023 and was temporarily suspended between 20 May 2021 and 31 July 2021 owing to the covid-19 pandemic.
Adult (age 20-80 years) patients with non-traumatic out-of-hospital cardiac arrest.
Biweekly randomised clusters of four participating advanced life support ambulance teams were assigned to insert either intravenous or intraosseous access.
The primary outcome was survival to hospital discharge. Secondary outcomes included return of spontaneous circulation, sustained return of spontaneous circulation (≥2 hours), and survival with favourable neurological outcomes (cerebral performance category score ≤2) at hospital discharge.
Among 1771 enrolled patients, 1732 (741 in the intraosseous group and 991 in the intravenous group) were included in the primary analysis (median age 65.0 years; 1234 (71.2%) men). In the intraosseous group, 79 (10.7%) patients were discharged alive, compared with 102 (10.3%) patients in the intravenous group (odds ratio 1.04, 95% confidence interval 0.76 to 1.42; P=0.81). The odds ratio of intraosseous versus intravenous access was 1.23 (0.89 to 1.69; P=0.21) for pre-hospital return of spontaneous circulation, 0.92 (0.75 to 1.13; P=0.44) for sustained return of spontaneous circulation, and 1.17 (0.82 to 1.66; P=0.39) for survival with favourable neurological outcomes.
Among adults with non-traumatic out-of-hospital cardiac arrest, initial attempts to establish vascular access through the intraosseous route did not result in different outcomes compared with intravenous access in terms of the proportion of patients surviving to hospital discharge, pre-hospital return of spontaneous circulation, sustained return of spontaneous circulation, and favourable neurological outcomes.
NCT04135547ClinicalTrials.gov NCT04135547.