JAMA: 多中心随机对照提示床旁即时CPR培训或无益于提升心脏骤停存活患儿神经系统转归

Abstract

Importance: Approximately 40% of children who experience an in-hospital cardiac arrest survive to hospital discharge. Achieving threshold intra-arrest diastolic blood pressure (BP) targets during cardiopulmonary resuscitation (CPR) and systolic BP targets after the return of circulation may be associated with improved outcomes.

重要性：约40%发生院内心脏骤停的儿童存活至出院。心肺复苏(CPR)期间达到停搏内舒张压(BP)阈值目标和循环恢复后达到收缩压目标可能与结局改善相关。

Objective: To evaluate the effectiveness of a bundled intervention comprising physiologically focused CPR training at the point of care and structured clinical event debriefings.

目的：评价由床旁生理关注的CPR培训和结构化临床事件汇报组成的捆绑干预的有效性。

Design, setting, and participants: A parallel, hybrid stepped-wedge, cluster randomized trial (Improving Outcomes from Pediatric Cardiac Arrest-the ICU-Resuscitation Project [ICU-RESUS]) involving 18 pediatric intensive care units (ICUs) from 10 clinical sites in the US. In this hybrid trial, 2 clinical sites were randomized to remain in the intervention group and 2 in the control group for the duration of the study, and 6 were randomized to transition from the control condition to the intervention in a stepped-wedge fashion. The index (first) CPR events of 1129 pediatric ICU patients were included between October 1, 2016, and March 31, 2021, and were followed up to hospital discharge (final follow-up was April 30, 2021).

设计、环境和参与者：一项平行、混合阶梯式楔形、整群随机试验（改善儿科心脏骤停的结局-ICU复苏项目[ICU-RESUS]），涉及来自美国10家临床研究中心的18家儿科重症监护室(ICU)。在这项混合试验中，2个临床研究中心被随机分配在研究期间留在干预组，2个在对照组，6个被随机分配以阶梯式楔形方式从对照条件过渡到干预。纳入了2016年10月1日至2021年3月31日期间1129例儿科ICU患者的指数（首次）CPR事件，并随访至出院（最终随访日期为2021年4月30日）。

Intervention: During the intervention period (n = 526 patients), a 2-part ICU resuscitation quality improvement bundle was implemented, consisting of CPR training at the point of care on a manikin (48 trainings/unit per month) and structured physiologically focused debriefings of cardiac arrest events (1 debriefing/unit per month). The control period (n = 548 patients) consisted of usual pediatric ICU management of cardiac arrest.

干预措施：在干预期间（n = 526例患者），实施了2部分ICU复苏质量改善组合，包括床旁人体模型干预措施：在干预期间（n = 526例患者），实施了2部分ICU复苏质量改善组合，包括床旁人体模型CPR培训（每月48次培训/单位）和心脏骤停事件的结构化生理学重点汇报（每月1次汇报/单位）。对照期（n = 548例患者）包括心脏骤停的常规儿科ICU管理。

Main outcomes and measures: The primary outcome was survival to hospital discharge with a favorable neurologic outcome defined as a Pediatric Cerebral Performance Category score of 1 to 3 or no change from baseline (score range, 1 [normal] to 6 [brain death or death]). The secondary outcome was survival to hospital discharge.

主要结局和指标：主要结局为存活至出院，具有良好的神经系统结局，定义为儿科脑功能分类评分1-3或较基线无变化（评分范围，1[正常]至6[脑死亡或死亡]）。次要结局是存活至出院。

Results: Among 1389 cardiac arrests experienced by 1276 patients, 1129 index CPR events (median patient age, 0.6 [IQR, 0.2-3.8] years; 499 girls [44%]) were included and 1074 were analyzed in the primary analysis. There was no significant difference in the primary outcome of survival to hospital discharge with favorable neurologic outcomes in the intervention group (53.8%) vs control (52.4%); risk difference (RD), 3.2% (95% CI, -4.6% to 11.4%); adjusted OR, 1.08 (95% CI, 0.76 to 1.53). There was also no significant difference in survival to hospital discharge in the intervention group (58.0%) vs control group (56.8%); RD, 1.6% (95% CI, -6.2% to 9.7%); adjusted OR, 1.03 (95% CI, 0.73 to 1.47).

结果：在1276例患者发生的1389例心脏骤停中，纳入了1129例指标CPR事件（中位患者年龄，0.6[IQR，0.2-3.8]岁；499例女孩[44%]），1074例被纳入主要分析。干预组(53.8%)与对照组(52.4%)相比，主要结局存活至出院无显著差异，神经系统结局有利；风险差异(RD)，3.2%（95%CI，-4.6%至11.4%）；校正OR，1.08（95%CI，0.76至1.53）。干预组(58.0%)与对照组(56.8%)的出院存活率也无显著差异；RD，1.6%（95%CI，-6.2%至9.7%）；校正OR，1.03（95%CI，0.73至1.47）。

Conclusions and relevance: In this randomized clinical trial conducted in 18 pediatric intensive care units, a bundled intervention of cardiopulmonary resuscitation training at the point of care and physiologically focused structured debriefing, compared with usual care, did not significantly improve patient survival to hospital discharge with favorable neurologic outcome among pediatric patients who experienced cardiac arrest in the ICU.

结论和相关性：在18家儿科重症监护室进行的随机临床试验中，与常规护理相比，床旁心肺复苏培训的捆绑干预和以生理学为重点的结构化汇报，在ICU发生心脏骤停的儿科患者中，未显著改善患者至出院的生存率，具有良好的神经系统结局。

Trial registration: ClinicalTrials.gov Identifier: NCT02837497.