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生理床边心肺复苏培训对儿科 ICU 心搏骤停患者生存和神经功能良好结局的影响:一项随机临床试验。

Effect of Physiologic Point-of-Care Cardiopulmonary Resuscitation Training on Survival With Favorable Neurologic Outcome in Cardiac Arrest in Pediatric ICUs: A Randomized Clinical Trial.

机构信息

Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia.

Department of Pediatrics, University of Utah, Salt Lake City.

出版信息

JAMA. 2022 Mar 8;327(10):934-945. doi: 10.1001/jama.2022.1738.

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.

OBJECTIVE

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

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).

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.

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.

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).

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.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02837497.

摘要

重要性

大约 40% 在医院经历心脏骤停的儿童存活至出院。在心肺复苏期间达到阈内舒张压(BP)目标和在循环恢复后达到收缩压目标可能与改善预后相关。

目的

评估由关注生理的心肺复苏培训和结构化临床事件讨论组成的捆绑干预措施的有效性。

设计、设置和参与者:一项在美国 10 个临床地点的 18 个儿科重症监护病房(ICU)参与的平行、混合分步楔形、群组随机试验(改善儿科心脏骤停的结果-ICU-复苏项目[ICU-RESUS])。在这项混合试验中,2 个临床地点被随机分配在研究期间保持在干预组,2 个在对照组,6 个以分步楔形的方式随机过渡到对照组。1129 名儿科 ICU 患者的指数(第一次)CPR 事件于 2016 年 10 月 1 日至 2021 年 3 月 31 日之间纳入,并随访至出院(最终随访时间为 2021 年 4 月 30 日)。

干预

在干预期间(n=526 名患者),实施了一个由心肺复苏质量改进组成的两部分捆绑包,包括在模型上进行关注生理的心肺复苏培训(每个 ICU 每月 48 次培训)和对心脏骤停事件进行结构化关注生理的讨论(每个 ICU 每月 1 次讨论)。对照组(n=548 名患者)由儿科 ICU 心脏骤停的常规管理组成。

主要结果和措施

主要结局是存活至出院且神经功能良好的患者比例,定义为儿科脑功能表现类别评分 1 至 3 或与基线相比无变化(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。

结果

在 1276 名患者经历的 1389 次心脏骤停中,纳入了 1129 次指数 CPR 事件(中位数患者年龄,0.6[IQR,0.2-3.8]岁;499 名女孩[44%]),并对 1074 次进行了主要分析。在干预组(53.8%)与对照组(52.4%)的主要结局即存活至出院且神经功能良好的患者比例之间,没有显著差异;风险差异(RD)为 3.2%(95%CI,-4.6%至 11.4%);调整后的 OR 为 1.08(95%CI,0.76 至 1.53)。干预组(58.0%)与对照组(56.8%)的存活至出院患者比例也没有显著差异;RD 为 1.6%(95%CI,-6.2%至 9.7%);调整后的 OR 为 1.03(95%CI,0.73 至 1.47)。

结论和相关性

在这项在 18 个儿科重症监护病房进行的随机临床试验中,与常规护理相比,在床边进行心肺复苏培训和进行关注生理的结构化讨论的捆绑式干预措施并没有显著改善儿科 ICU 心脏骤停患者存活至出院且神经功能良好的患者比例。

试验注册

ClinicalTrials.gov 标识符:NCT02837497。

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