. 2018 Apr 3;19(1):213.

doi: 10.1186/s13063-018-2590-y.

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

Ron W Reeder¹, Alan Girling², Heather Wolfe³, Richard Holubkov⁴, Robert A Berg³, Maryam Y Naim³, Kathleen L Meert⁵, Bradley Tilford⁵, Joseph A Carcillo⁶, Melinda Hamilton⁶, Matthew Bochkoris⁶, Mark Hall⁷, Tensing Maa⁷, Andrew R Yates⁷, Anil Sapru⁸, Robert Kelly⁸, Myke Federman⁸, J Michael Dean⁴, Patrick S McQuillen⁹, Deborah Franzon⁹, Murray M Pollack¹⁰, Ashley Siems¹⁰, John Diddle¹⁰, David L Wessel¹¹, Peter M Mourani¹², Carleen Zebuhr¹², Robert Bishop¹², Stuart Friess¹³, Candice Burns¹³, Shirley Viteri¹⁴, David A Hehir¹⁴, R Whitney Coleman⁴, Tammara L Jenkins¹⁵, Daniel A Notterman¹⁶, Robert F Tamburro¹⁵, Robert M Sutton³; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN)

Affiliations

¹ Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT, 84108, USA. ron.reeder@hsc.utah.edu.
² The Learning Centre Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
³ Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA.
⁴ Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.
⁵ Department of Pediatrics, Children's Hospital of Michigan, Wayne State University, Detroit, MI, USA.
⁶ Department of Critical Care Medicine, Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, PA, USA.
⁷ Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University, Columbus, OH, USA.
⁸ Department of Pediatrics, UCLA Mattel Children's Hospital, University of California, Los Angeles, Los Angeles, CA, USA.
⁹ Department of Pediatrics, Benioff Children's Hospital, University of California, San Francisco, San Francisco, CA, USA.
¹⁰ Department of Pediatrics, Children's National Medical Center, George Washington University School of Medicine, Washington, DC, USA.
¹¹ Department of Pediatrics, Children's National Medical Center, Washington, DC, USA.
¹² Department of Pediatrics, Denver Children's Hospital, University of Colorado, Denver, CO, USA.
¹³ Department of Pediatrics, Washington University Medical Center, St. Louis, MO, USA.
¹⁴ Department of Pediatrics, Nemours Alfred I. DuPont Hospital for Children, Wilmington, DE, USA.
¹⁵ Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
¹⁶ Department of Pediatrics, Milton S. Hershey Medical Center, Pennsylvania State University, Hershey, PA, USA.

PMID: 29615134
PMCID: PMC5883604
DOI: 10.1186/s13063-018-2590-y

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

Ron W Reeder et al. Trials. 2018.

. 2018 Apr 3;19(1):213.

doi: 10.1186/s13063-018-2590-y.

Authors

Affiliations

¹ Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT, 84108, USA. ron.reeder@hsc.utah.edu.
² The Learning Centre Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
³ Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA.
⁴ Department of Pediatrics, University of Utah, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.
⁵ Department of Pediatrics, Children's Hospital of Michigan, Wayne State University, Detroit, MI, USA.
⁶ Department of Critical Care Medicine, Children's Hospital of Pittsburgh, University of Pittsburgh, Pittsburgh, PA, USA.
⁷ Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University, Columbus, OH, USA.
⁸ Department of Pediatrics, UCLA Mattel Children's Hospital, University of California, Los Angeles, Los Angeles, CA, USA.
⁹ Department of Pediatrics, Benioff Children's Hospital, University of California, San Francisco, San Francisco, CA, USA.
¹⁰ Department of Pediatrics, Children's National Medical Center, George Washington University School of Medicine, Washington, DC, USA.
¹¹ Department of Pediatrics, Children's National Medical Center, Washington, DC, USA.
¹² Department of Pediatrics, Denver Children's Hospital, University of Colorado, Denver, CO, USA.
¹³ Department of Pediatrics, Washington University Medical Center, St. Louis, MO, USA.
¹⁴ Department of Pediatrics, Nemours Alfred I. DuPont Hospital for Children, Wilmington, DE, USA.
¹⁵ Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
¹⁶ Department of Pediatrics, Milton S. Hershey Medical Center, Pennsylvania State University, Hershey, PA, USA.

PMID: 29615134
PMCID: PMC5883604
DOI: 10.1186/s13063-018-2590-y

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.

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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**
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**
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

See this image and copyright information in PMC

References

1. Tress EE, et al. Cardiac arrest in children. J Emerg Trauma Shock. 2010;3(3):267–272. doi: 10.4103/0974-2700.66528. - DOI - PMC - PubMed
1. Berg RA, et al. Ratio of PICU versus ward cardiopulmonary resuscitation events is increasing. Crit Care Med. 2013;41(10):2292–2297. doi: 10.1097/CCM.0b013e31828cf0c0. - DOI - PMC - PubMed
1. Girotra S, et al. Trends in survival after in-hospital cardiac arrest. N Engl J Med. 2012;367(20):1912–20. doi: 10.1056/NEJMoa1109148. - DOI - PMC - PubMed
1. Girotra S, et al. Survival trends in pediatric in-hospital cardiac arrests: an analysis from Get With the Guidelines-Resuscitation. Circ Cardiovasc Qual Outcomes. 2013;6(1):42–49. doi: 10.1161/CIRCOUTCOMES.112.967968. - DOI - PMC - PubMed
1. Abella BS, et al. Quality of cardiopulmonary resuscitation during in-hospital cardiac arrest. JAMA. 2005;293(3):305–310. doi: 10.1001/jama.293.3.305. - DOI - PubMed

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

Affiliations

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

Authors

Affiliations

Abstract

Conflict of interest statement

Ethics approval and consent to participate

Consent for publication

Competing interests

Publisher’s Note

Figures

References

Publication types

MeSH terms

Associated data

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical

Miscellaneous