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,
for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network (CPCCRN)
Affiliations
Ron W. Reeder
Department of Pediatrics, University of Utah
Alan Girling
The Learning Centre Institute of Applied Health Research, University of Birmingham
Heather Wolfe
Department of Anesthesiology and Critical Care Medicine, The Children’s Hospital of Philadelphia, University of Pennsylvania
Richard Holubkov
Department of Pediatrics, University of Utah
Robert A. Berg
Department of Anesthesiology and Critical Care Medicine, The Children’s Hospital of Philadelphia, University of Pennsylvania
Maryam Y. Naim
Department of Anesthesiology and Critical Care Medicine, The Children’s Hospital of Philadelphia, University of Pennsylvania
Kathleen L. Meert
Department of Pediatrics, Children’s Hospital of Michigan, Wayne State University
Bradley Tilford
Department of Pediatrics, Children’s Hospital of Michigan, Wayne State University
Joseph A. Carcillo
Department of Critical Care Medicine, Children’s Hospital of Pittsburgh, University of Pittsburgh
Melinda Hamilton
Department of Critical Care Medicine, Children’s Hospital of Pittsburgh, University of Pittsburgh
Matthew Bochkoris
Department of Critical Care Medicine, Children’s Hospital of Pittsburgh, University of Pittsburgh
Mark Hall
Department of Pediatrics, Nationwide Children’s Hospital, The Ohio State University
Tensing Maa
Department of Pediatrics, Nationwide Children’s Hospital, The Ohio State University
Andrew R. Yates
Department of Pediatrics, Nationwide Children’s Hospital, The Ohio State University
Anil Sapru
Department of Pediatrics, UCLA Mattel Children’s Hospital, University of California, Los Angeles
Robert Kelly
Department of Pediatrics, UCLA Mattel Children’s Hospital, University of California, Los Angeles
Myke Federman
Department of Pediatrics, UCLA Mattel Children’s Hospital, University of California, Los Angeles
J. Michael Dean
Department of Pediatrics, University of Utah
Patrick S. McQuillen
Department of Pediatrics, Benioff Children’s Hospital, University of California, San Francisco
Deborah Franzon
Department of Pediatrics, Benioff Children’s Hospital, University of California, San Francisco
Murray M. Pollack
Department of Pediatrics, Children’s National Medical Center, George Washington University School of Medicine
Ashley Siems
Department of Pediatrics, Children’s National Medical Center, George Washington University School of Medicine
John Diddle
Department of Pediatrics, Children’s National Medical Center, George Washington University School of Medicine
David L. Wessel
Department of Pediatrics, Children’s National Medical Center
Peter M. Mourani
Department of Pediatrics, Denver Children’s Hospital, University of Colorado
Carleen Zebuhr
Department of Pediatrics, Denver Children’s Hospital, University of Colorado
Robert Bishop
Department of Pediatrics, Denver Children’s Hospital, University of Colorado
Stuart Friess
Department of Pediatrics, Washington University Medical Center
Candice Burns
Department of Pediatrics, Washington University Medical Center
Shirley Viteri
Department of Pediatrics, Nemours Alfred I. DuPont Hospital for Children
David A. Hehir
Department of Pediatrics, Nemours Alfred I. DuPont Hospital for Children
R. Whitney Coleman
Department of Pediatrics, University of Utah
Tammara L. Jenkins
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Daniel A. Notterman
Department of Pediatrics, Milton S. Hershey Medical Center, Pennsylvania State University
Robert F. Tamburro
Eunice Kennedy Shriver National Institute of Child Health and Human Development
Robert M. Sutton
Department of Anesthesiology and Critical Care Medicine, The Children’s Hospital of Philadelphia, University of Pennsylvania
for the 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.
