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

Abstract

BackgroundQuality 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/designThis 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.DiscussionTo 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 registrationClinicalTrials.gov, NCT02837497. Registered on July 19, 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2590-y) contains supplementary material, which is available to authorized users.

Information content of stepped‐wedge designs when treatment effect heterogeneity and/or implementation periods are present

“…During such periods, clusters are considered to be neither fully exposed nor fully unexposed; thus, data collection may be put on hold or any collected data may be excluded from the analysis to reduce bias in the estimation of treatment effects . Such implementation periods need to be explicitly incorporated into the design, as was done, for example, by Reeder et al and Foot et al The middle panel of Figure displays an example of a nine treatment‐sequence design with one implementation period in each treatment sequence: the total length of the trial is increased to accommodate the implementation period in each cluster so that all of these designs have the same total number of measurements. The bottom panel of Figure displays the design with five implementation periods.…”

The Temporal Association of the COVID-19 Pandemic and Pediatric Cardiopulmonary Resuscitation Quality and Outcomes*

“…The ICU-RESUS study was a multicenter, parallel, hybrid stepped-wedge cluster-randomized trial evaluating a two-part quality improvement bundle of physiology-directed point-of-care training and structured postresuscitation event debriefing compared with usual care ( 12 , 13 ). It was conducted in 18 pediatric and pediatric cardiac ICUs at 10 clinical sites in the United States.…”

“…The association between these widespread resuscitation system changes and pediatric IHCA outcomes and CPR quality during the COVID-19 pandemic is unknown. To address this knowledge gap, we performed a secondary retrospective analysis of data leveraged from a prospective, multicenter, cluster-randomized interventional trial (The ICU-RESUScitation Project [ICU-RESUS]; NCT02837497) ( 12 , 13 ). Our objective was to compare pediatric IHCA outcomes and CPR quality metrics in the first year of the COVID-19 pandemic to the year prior to the pandemic.…”

Critical Cardiopulmonary Event Series: Four Simulations for Pediatric ICU Fellows, Critical Care Nurses, and Pediatric Residents

“…Cardiopulmonary events arising from congenital or acquired heart diseases are relatively infrequent in the scope of pediatric critical care practice but can be associated with significant morbidity and mortality when encountered. 1,2 Thus, there is an inherent need for pediatric critical care providers to be equipped with the skills required to recognize and manage such high-acuity/low-frequency events. The challenging paradox is that these events require high-functioning teams (rather than individuals) to avoid adverse outcomes.…”

“…5,6 We included Kawasaki disease because it represents the leading case of acquired heart disease in developed countries. 2,7 Most children with Kawasaki disease are cared for outside of the ICU, and those with coronary artery aneurysms may be observed in the PICU without team members fully appreciating the potential for rapid and catastrophic deterioration. We included a case of myocarditis to highlight the rather nonspecific presentation that these patients may have, their potential for deterioration from pump failure and/or dysrhythmia, and the judicious decision making and contingency planning they require.…”