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)

doi:10.1186/s13063-018-2590-y

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

Trials. 2018 Apr 3;19(1):213. doi: 10.1186/s13063-018-2590-y.

Authors

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. [email protected].
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.

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.

Publication types

Clinical Trial Protocol

MeSH terms

Adolescent
Age Factors
Cardiopulmonary Resuscitation / adverse effects
Cardiopulmonary Resuscitation / education*
Cardiopulmonary Resuscitation / mortality
Cardiopulmonary Resuscitation / standards
Child
Child, Preschool
Female
Heart Arrest / diagnosis
Heart Arrest / mortality
Heart Arrest / therapy*
Hospital Mortality
Humans
Infant
Infant, Newborn
Inservice Training / methods*
Intensive Care Units, Pediatric* / standards
Male
Medical Staff, Hospital / education*
Medical Staff, Hospital / standards
Multicenter Studies as Topic
Patient Care Team* / standards
Point-of-Care Systems
Quality Improvement*
Randomized Controlled Trials as Topic
Risk Factors
Time Factors
Treatment Outcome
United States

Associated data

ClinicalTrials.gov/NCT02837497

Abstract

Publication types

MeSH terms

Associated data

Grants and funding