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临床试验/NCT02837497
NCT02837497已完成不适用

Improving Outcomes After Pediatric Cardiac Arrest

Children's Hospital of Philadelphia2 个研究点 分布在 1 个国家目标入组 1,127 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,127
试验地点
2
主要终点
Good neurological survival

研究概览

简要总结

Pediatric cardiac arrest affects thousands of hospitalized children each year. High quality cardiopulmonary resuscitation (CPR) saves lives, but is difficult to achieve. The objective of this study is to determine if a novel patient-centric resuscitation care improvement bundle consisting of bedside CPR training and multidisciplinary reviews of each cardiac arrest improves CPR quality and survival outcomes in a multi-center trial.

详细描述

Pediatric cardiac arrest affects thousands of hospitalized children each year. Progressive heart and lung failure is a predisposing cause in the majority of these events. While cardiac arrest survival outcomes have improved over the last decade, more than half of these children will not live to hospital discharge. As brain injury complicates care in those who do survive, the burden to these children and the public's health is substantial.

Cardiopulmonary resuscitation (CPR) - the medical procedure of providing chest compressions and ventilations during cardiac arrest - is life saving, and higher quality CPR is more effective at doing so. However, providing high quality care during the resuscitation of a child is difficult. Attempts to improve care through conventional training methods have not been successful; therefore, interventions to improve the quality of pediatric CPR and outcomes are needed.

The objective of this study is to determine if a novel resuscitation care improvement bundle that improved outcomes in a single center intensive care unit (ICU) efficacy study is generalizable to other pediatric institutions in a multi-center effectiveness trial. The ICU-Resuscitation (ICU-RESUS) bundle includes: 1) CPR training at the point-of-care (in the ICU rather than a classroom away from patients); and 2) interdisciplinary structured reviews of each cardiac arrest that emphasize patient-centric physiology intended to optimize intra-arrest and post-arrest care. The ICU-RESUS bundle substantially improved CPR quality and nearly doubled the number of children surviving their event during the single center efficacy trial. In this study, a multi-institutional parallel stepped-wedge hybrid cluster-randomized trial, which leverages the existing infrastructure of the National Institute of Child Health and Human Development (NICHD)-funded Collaborative Pediatric Critical Care Research Network (CPCCRN), is proposed with the following aims: 1) Evaluate the effectiveness of the ICU-RESUS interventional bundle to improve outcomes of children treated for an ICU cardiac arrest; and 2) Evaluate the effectiveness of the ICU-RESUS interventional bundle to improve the quality of CPR provided by ICU healthcare providers in the population of children treated for an ICU cardiac arrest.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
37 Weeks 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than or equal to 37 weeks and less than or equal to18 years of age;
  • AND Received CPR in the ICU setting

排除标准

  • Pre-existing terminal illness and patient not expected to survive to hospital discharge.
  • Lack of commitment to aggressive ICU therapies.
  • Brain death determination prior to CPR event.
  • First CPR event associated with this hospital admission was an out-of-hospital CPR event.

结局指标

主要结局

Good neurological survival

时间窗: Baseline and hospital discharge

Pediatric cerebral performance category of less than or equal to 3 or no change from baseline.

次要结局

  • Excellent CPR(During cardiopulmonary resuscitation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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