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The ICU-Resuscitation Project (ICU-RESUS)

Improving Outcomes After Pediatric Cardiac Arrest

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02837497
Acronym
ICU-RESUS
Enrollment
1127
Registered
2016-07-19
Start date
2016-10-31
Completion date
2021-03-31
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

pediatric, heart arrest

Brief summary

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

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.

Interventions

OTHERICU-RESUS CPR Improvement Bundle

1. Point-of-care CPR training 2. Post-cardiac arrest educational debriefings

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Utah
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Good neurological survivalBaseline and hospital dischargePediatric cerebral performance category of less than or equal to 3 or no change from baseline.

Secondary

MeasureTime frameDescription
Excellent CPRDuring cardiopulmonary resuscitationA 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%.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026