改善小儿心脏骤停后的预后——重症监护病房复苏项目：一项随机对照试验的研究方案
Improving outcomes after pediatric cardiac arrest - the ICU-Resuscitation Project: study protocol for a randomized controlled trial.
作者信息
Reeder Ron W, Girling Alan, Wolfe Heather, Holubkov Richard, Berg Robert A, Naim Maryam Y, Meert Kathleen L, Tilford Bradley, Carcillo Joseph A, Hamilton Melinda, Bochkoris Matthew, Hall Mark, Maa Tensing, Yates Andrew R, Sapru Anil, Kelly Robert, Federman Myke, Michael Dean J, McQuillen Patrick S, Franzon Deborah, Pollack Murray M, Siems Ashley, Diddle John, Wessel David L, Mourani Peter M, Zebuhr Carleen, Bishop Robert, Friess Stuart, Burns Candice, Viteri Shirley, Hehir David A, Whitney Coleman R, Jenkins Tammara L, Notterman Daniel A, Tamburro Robert F, Sutton Robert M
机构信息
Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.
The Learning Centre Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
出版信息
Trials. 2018 Apr 3;19(1):213. doi: 10.1186/s13063-018-2590-y.
BACKGROUND
Quality of cardiopulmonary resuscitation (CPR) is associated with survival, but recommended guidelines are often not met, and less than half the children with an in-hospital arrest will survive to discharge. A single-center before-and-after study demonstrated that outcomes may be improved with a novel training program in which all pediatric intensive care unit staff are encouraged to participate in frequent CPR refresher training and regular, structured resuscitation debriefings focused on patient-centric physiology.
METHODS/DESIGN: This ongoing trial will assess whether a program of structured debriefings and point-of-care bedside practice that emphasizes physiologic resuscitation targets improves the rate of survival to hospital discharge with favorable neurologic outcome in children receiving CPR in the intensive care unit. This study is designed as a hybrid stepped-wedge trial in which two of ten participating hospitals are randomly assigned to enroll in the intervention group and two are assigned to enroll in the control group for the duration of the trial. The remaining six hospitals enroll initially in the control group but will transition to enrolling in the intervention group at randomly assigned staggered times during the enrollment period.
DISCUSSION
To our knowledge, this is the first implementation of a hybrid stepped-wedge design. It was chosen over a traditional stepped-wedge design because the resulting improvement in statistical power reduces the required enrollment by 9 months (14%). However, this design comes with additional challenges, including logistics of implementing an intervention prior to the start of enrollment. Nevertheless, if results from the single-center pilot are confirmed in this trial, it will have a profound effect on CPR training and quality improvement initiatives.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02837497 . Registered on July 19, 2016.
背景
心肺复苏（CPR）的质量与生存率相关，但推荐的指南常常未得到遵循，且住院期间心脏骤停的儿童中只有不到一半能存活至出院。一项单中心前后对照研究表明，一项新的培训项目可能会改善预后，该项目鼓励所有儿科重症监护病房的工作人员参加频繁的CPR复习培训以及以患者为中心的生理学为重点的定期、结构化复苏汇报。
方法/设计：这项正在进行的试验将评估一个强调生理学复苏目标的结构化汇报和床边即时实践项目，是否能提高重症监护病房接受CPR的儿童存活至出院且神经功能良好的比例。本研究设计为混合阶梯楔形试验，在参与试验的十家医院中，随机分配两家加入干预组，两家在试验期间加入对照组。其余六家医院最初加入对照组，但在入组期间将在随机分配的交错时间过渡到加入干预组。
讨论
据我们所知，这是混合阶梯楔形设计的首次应用。选择这种设计而非传统的阶梯楔形设计，是因为由此带来的统计效能提高使所需入组时间减少了9个月（14%）。然而，这种设计带来了额外的挑战，包括在入组开始前实施干预的后勤工作。尽管如此，如果单中心试点的结果在本试验中得到证实，它将对CPR培训和质量改进举措产生深远影响。
试验注册
ClinicalTrials.gov，NCT02837497。于2016年7月19日注册。
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