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A Randomized Trial of Drug Route in Out-of-Hospital Cardiac Arrest.
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-10-31 , DOI: 10.1056/nejmoa2407780 Keith Couper,Chen Ji,Charles D Deakin,Rachael T Fothergill,Jerry P Nolan,John B Long,James M Mason,Felix Michelet,Chloe Norman,Henry Nwankwo,Tom Quinn,Anne-Marie Slowther,Michael A Smyth,Kath R Starr,Alison Walker,Sara Wood,Steve Bell,Gemma Bradley,Martina Brown,Shona Brown,Emma Burrow,Karl Charlton,Andrew Claxton Dip,Victoria Dra'gon,Christine Evans,Jakob Falloon,Theresa Foster,Justin Kearney,Nigel Lang,Matthew Limmer,Adam Mellett-Smith,Joshua Miller,Carla Mills,Ria Osborne,Nigel Rees,Robert E S Spaight,Gemma L Squires,Belinda Tibbetts,Michelle Waddington,Gregory A Whitley,Jason V Wiles,Julia Williams,Sarah Wiltshire,Adam Wright,Ranjit Lall,Gavin D Perkins,
The New England Journal of Medicine ( IF 96.2 ) Pub Date : 2024-10-31 , DOI: 10.1056/nejmoa2407780 Keith Couper,Chen Ji,Charles D Deakin,Rachael T Fothergill,Jerry P Nolan,John B Long,James M Mason,Felix Michelet,Chloe Norman,Henry Nwankwo,Tom Quinn,Anne-Marie Slowther,Michael A Smyth,Kath R Starr,Alison Walker,Sara Wood,Steve Bell,Gemma Bradley,Martina Brown,Shona Brown,Emma Burrow,Karl Charlton,Andrew Claxton Dip,Victoria Dra'gon,Christine Evans,Jakob Falloon,Theresa Foster,Justin Kearney,Nigel Lang,Matthew Limmer,Adam Mellett-Smith,Joshua Miller,Carla Mills,Ria Osborne,Nigel Rees,Robert E S Spaight,Gemma L Squires,Belinda Tibbetts,Michelle Waddington,Gregory A Whitley,Jason V Wiles,Julia Williams,Sarah Wiltshire,Adam Wright,Ranjit Lall,Gavin D Perkins,
BACKGROUND
In patients with out-of-hospital cardiac arrest, the effectiveness of drugs such as epinephrine is highly time-dependent. An intraosseous route of drug administration may enable more rapid drug administration than an intravenous route; however, its effect on clinical outcomes is uncertain.
METHODS
We conducted a multicenter, open-label, randomized trial across 11 emergency medical systems in the United Kingdom that involved adults in cardiac arrest for whom vascular access for drug administration was needed. Patients were randomly assigned to receive treatment from paramedics by means of an intraosseous-first or intravenous-first vascular access strategy. The primary outcome was survival at 30 days. Key secondary outcomes included any return of spontaneous circulation and favorable neurologic function at hospital discharge (defined by a score of 3 or less on the modified Rankin scale, on which scores range from 0 to 6, with higher scores indicating greater disability). No adjustment for multiplicity was made.
RESULTS
A total of 6082 patients were assigned to a trial group: 3040 to the intraosseous group and 3042 to the intravenous group. At 30 days, 137 of 3030 patients (4.5%) in the intraosseous group and 155 of 3034 (5.1%) in the intravenous group were alive (adjusted odds ratio, 0.94; 95% confidence interval [CI], 0.68 to 1.32; P = 0.74). At the time of hospital discharge, a favorable neurologic outcome was observed in 80 of 2994 patients (2.7%) in the intraosseous group and in 85 of 2986 (2.8%) in the intravenous group (adjusted odds ratio, 0.91; 95% CI, 0.57 to 1.47); a return of spontaneous circulation at any time occurred in 1092 of 3031 patients (36.0%) and in 1186 of 3035 patients (39.1%), respectively (adjusted odds ratio, 0.86; 95% CI, 0.76 to 0.97). During the trial, one adverse event, which occurred in the intraosseous group, was reported.
CONCLUSIONS
Among adults with out-of-hospital cardiac arrest requiring drug therapy, the use of an intraosseous-first vascular access strategy did not result in higher 30-day survival than an intravenous-first strategy. (Funded by the National Institute for Health and Care Research; PARAMEDIC-3 ISRCTN Registry number, ISRCTN14223494.).
中文翻译:
院外心脏骤停药物途径的随机试验。
背景 在院外心脏骤停患者中,肾上腺素等药物的有效性高度依赖于时间。骨内给药途径可能比静脉给药途径更快速;然而,它对临床结局的影响是不确定的。方法 我们在英国的 11 个紧急医疗系统中进行了一项多中心、开放标签、随机试验,涉及需要血管通路进行给药的心脏骤停成人。患者被随机分配接受护理人员的治疗,采用骨内优先或静脉内血管通路策略。主要结局是 30 天生存率。关键的次要结局包括出院时自主循环的恢复和良好的神经功能(定义为改良 Rankin 量表的评分为 3 分或更低,评分范围为 0 到 6,分数越高表示残疾程度越高)。没有对多重性进行调整。结果 共 6082 例患者被分配到试验组: 骨内组 3040 例,静脉组 3042 例。30 天时,骨内组 3030 例患者中有 137 例 (4.5%) 存活,静脉组 3034 例患者中有 155 例 (5.1%) 存活(校正比值比,0.94;95% 置信区间 [CI],0.68 至 1.32;P = 0.74)。出院时,骨内组 2994 例患者中有 80 例 (2.7%) 观察到良好的神经系统结局,静脉内组 2986 例中有 85 例 (2.8%) 观察到良好的神经系统结局(校正比值比,0.91;95% CI,0.57 至 1.47);3031 名患者中有 1092 名 (36.0%) 和 3035 名患者中有 1186 名 (39.1%) 在任何时间自主循环恢复(调整比值比,0.86;95% CI,0.76 至 0。在试验期间,报告了 1 例不良事件,发生在骨内组。结论 在需要药物治疗的院外心脏骤停成人中,使用骨内优先血管通路策略的 30 天生存率并不高于静脉内优先策略。(由国家健康与护理研究所资助;PARAMEDIC-3 ISRCTN 登记号,ISRCTN14223494.)。
更新日期:2024-10-31
中文翻译:
院外心脏骤停药物途径的随机试验。
背景 在院外心脏骤停患者中,肾上腺素等药物的有效性高度依赖于时间。骨内给药途径可能比静脉给药途径更快速;然而,它对临床结局的影响是不确定的。方法 我们在英国的 11 个紧急医疗系统中进行了一项多中心、开放标签、随机试验,涉及需要血管通路进行给药的心脏骤停成人。患者被随机分配接受护理人员的治疗,采用骨内优先或静脉内血管通路策略。主要结局是 30 天生存率。关键的次要结局包括出院时自主循环的恢复和良好的神经功能(定义为改良 Rankin 量表的评分为 3 分或更低,评分范围为 0 到 6,分数越高表示残疾程度越高)。没有对多重性进行调整。结果 共 6082 例患者被分配到试验组: 骨内组 3040 例,静脉组 3042 例。30 天时,骨内组 3030 例患者中有 137 例 (4.5%) 存活,静脉组 3034 例患者中有 155 例 (5.1%) 存活(校正比值比,0.94;95% 置信区间 [CI],0.68 至 1.32;P = 0.74)。出院时,骨内组 2994 例患者中有 80 例 (2.7%) 观察到良好的神经系统结局,静脉内组 2986 例中有 85 例 (2.8%) 观察到良好的神经系统结局(校正比值比,0.91;95% CI,0.57 至 1.47);3031 名患者中有 1092 名 (36.0%) 和 3035 名患者中有 1186 名 (39.1%) 在任何时间自主循环恢复(调整比值比,0.86;95% CI,0.76 至 0。在试验期间,报告了 1 例不良事件,发生在骨内组。结论 在需要药物治疗的院外心脏骤停成人中,使用骨内优先血管通路策略的 30 天生存率并不高于静脉内优先策略。(由国家健康与护理研究所资助;PARAMEDIC-3 ISRCTN 登记号,ISRCTN14223494.)。