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Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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)

Published in: Trials | Issue 1/2018

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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.
Appendix
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Metadata
Title
Improving outcomes after pediatric cardiac arrest – the ICU-Resuscitation Project: study protocol for a randomized controlled trial
Authors
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)
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2590-y

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