Improving outcomes after pediatric cardiac arrest - the ICU-Resuscitation Project: study protocol for a randomized controlled trial

Ron W Reeder, Alan Girling, Heather Wolfe, Richard Holubkov, Robert A Berg, Maryam Y Naim, Kathleen L Meert, Bradley Tilford, Joseph A Carcillo, Melinda Hamilton, Matthew Bochkoris, Mark Hall, Tensing Maa, Andrew R Yates, Anil Sapru, Robert Kelly, Myke Federman, J Michael Dean, Patrick S McQuillen, Deborah Franzon, Murray M Pollack, Ashley Siems, John Diddle, David L Wessel, Peter M Mourani, Carleen Zebuhr, Robert Bishop, Stuart Friess, Candice Burns, Shirley Viteri, David A Hehir, R Whitney Coleman, Tammara L Jenkins, Daniel A Notterman, Robert F Tamburro, Robert M Sutton, Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN), Ron W Reeder, Alan Girling, Heather Wolfe, Richard Holubkov, Robert A Berg, Maryam Y Naim, Kathleen L Meert, Bradley Tilford, Joseph A Carcillo, Melinda Hamilton, Matthew Bochkoris, Mark Hall, Tensing Maa, Andrew R Yates, Anil Sapru, Robert Kelly, Myke Federman, J Michael Dean, Patrick S McQuillen, Deborah Franzon, Murray M Pollack, Ashley Siems, John Diddle, David L Wessel, Peter M Mourani, Carleen Zebuhr, Robert Bishop, Stuart Friess, Candice Burns, Shirley Viteri, David A Hehir, R Whitney Coleman, Tammara L Jenkins, Daniel A Notterman, Robert F Tamburro, Robert M Sutton, Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN)

Abstract

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.

Keywords: Cardiac arrest; Cardiopulmonary resuscitation (CPR); Hybrid; In-hospital; Pediatric; Stepped-wedge; Survival.

Conflict of interest statement

Ethics approval and consent to participate

This trial was reviewed and approved with waiver of consent by the University of Utah Institutional Review Board.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Comparison of cluster-randomized trial designs. This figure illustrates the concept of a hybrid stepped-wedge (HSW) design compared with a parallel group or traditional stepped-wedge (TSW) design. a Parallel design. b TSW design. c HSW design
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments. This figure illustrates the schedule of trial events, including enrollment, interventions, and assessments. Point-of-care practice occurs ≥ 48 times per month in each transitioned or transitioning intensive care unit (ICU). Debriefing occurs at least nine times per year at each transitioned or transitioning ICU. CPR Cardiopulmonary resuscitation, PCPC Pediatric Cerebral Performance Category scale, PRISM Pediatric Risk of Mortality score, a measure of illness severity based on assessments from 2 to 6 h prior to the CPR event

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