The ICU-Resuscitation Project (ICU-RESUS)

Study Overview
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Brief Summary
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Pediatric cardiac arrest affects thousands of hospitalized children each year. High quality cardiopulmonary resuscitation (CPR) saves lives, but is difficult to achieve. The objective of this study is to determine if a novel patient-centric resuscitation care improvement bundle consisting of bedside CPR training and multidisciplinary reviews of each cardiac arrest improves CPR quality and survival outcomes in a multi-center trial.

Detailed Description
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Pediatric cardiac arrest affects thousands of hospitalized children each year. Progressive heart and lung failure is a predisposing cause in the majority of these events. While cardiac arrest survival outcomes have improved over the last decade, more than half of these children will not live to hospital discharge. As brain injury complicates care in those who do survive, the burden to these children and the public's health is substantial. Cardiopulmonary resuscitation (CPR) - the medical procedure of providing chest compressions and ventilations during cardiac arrest - is life saving, and higher quality CPR is more effective at doing so. However, providing high quality care during the resuscitation of a child is difficult. Attempts to improve care through conventional training methods have not been successful; therefore, interventions to improve the quality of pediatric CPR and outcomes are needed. The objective of this study is to determine if a novel resuscitation care improvement bundle that improved outcomes in a single center intensive care unit (ICU) efficacy study is generalizable to other pediatric institutions in a multi-center effectiveness trial. The ICU-Resuscitation (ICU-RESUS) bundle includes: 1) CPR training at the point-of-care (in the ICU rather than a classroom away from patients); and 2) interdisciplinary structured reviews of each cardiac arrest that emphasize patient-centric physiology intended to optimize intra-arrest and post-arrest care. The ICU-RESUS bundle substantially improved CPR quality and nearly doubled the number of children surviving their event during the single center efficacy trial. In this study, a multi-institutional parallel stepped-wedge hybrid cluster-randomized trial, which leverages the existing infrastructure of the National Institute of Child Health and Human Development (NICHD)-funded Collaborative Pediatric Critical Care Research Network (CPCCRN), is proposed with the following aims: 1) Evaluate the effectiveness of the ICU-RESUS interventional bundle to improve outcomes of children treated for an ICU cardiac arrest; and 2) Evaluate the effectiveness of the ICU-RESUS interventional bundle to improve the quality of CPR provided by ICU healthcare providers in the population of children treated for an ICU cardiac arrest.

Official Title
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Improving Outcomes After Pediatric Cardiac Arrest

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Other: ICU-RESUS CPR Improvement Bundle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than or equal to 37 weeks and less than or equal to18 years of age; AND Received CPR in the ICU setting Exclusion Criteria: Pre-existing terminal illness and patient not expected to survive to hospital discharge. Lack of commitment to aggressive ICU therapies. Brain death determination prior to CPR event. First CPR event associated with this hospital admission was an out-of-hospital CPR event.

Ages Eligible for Study
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Minimum Age: 37 Weeks
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard ICU resuscitation practices | |
| Experimental: ICU-RESUS CPR Improvement Bundle<br>ICU-RESUS bundle implementation: 1) point-of-care bedside CPR training; and 2) post-cardiac arrest debriefings. | Other: ICU-RESUS CPR Improvement Bundle<br>* Point-of-care CPR training Post-cardiac arrest educational debriefings<br>* Other names: ICU-RESUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Good neurological survival | Pediatric cerebral performance category of less than or equal to 3 or no change from baseline. | Baseline and hospital discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excellent CPR | A composite variable of systolic blood pressure >60 mmHg for neonates, >80 mmHg for infants, or >100 mmHg for older patients AND compression rate between 100-120 / minute, AND a chest compression fraction greater than or equal to 80%. | During cardiopulmonary resuscitation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, heart arrest