The ICU-Resuscitation Project (ICU-RESUS) (ICU-RESUS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02837497|
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : December 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Other: ICU-RESUS CPR Improvement Bundle||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1540 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving Outcomes After Pediatric Cardiac Arrest|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
No Intervention: Control
Standard ICU resuscitation practices
Experimental: ICU-RESUS CPR Improvement Bundle
ICU-RESUS bundle implementation: 1) point-of-care bedside CPR training; and 2) post-cardiac arrest debriefings.
Other: ICU-RESUS CPR Improvement Bundle
Other Name: ICU-RESUS
- Good neurological survival [ Time Frame: Baseline and hospital discharge ]Pediatric cerebral performance category of less than or equal to 3 or no change from baseline.
- Excellent CPR [ Time Frame: During cardiopulmonary resuscitation ]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%.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837497
|Contact: Sharon Carbonara, BSN, RNfirstname.lastname@example.org|
|Contact: Kathryn Graham, BA||2155901859||GrahamK1@email.chop.edu|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Kathryn Graham, BA 215-590-1859 email@example.com|
|Principal Investigator:||Robert Sutton, MD MSCE||Children's Hospital of Philadelphia|