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The ICU-Resuscitation Project (ICU-RESUS) (ICU-RESUS)

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ClinicalTrials.gov Identifier: NCT02837497
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : January 19, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Utah
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Other: ICU-RESUS CPR Improvement Bundle Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1540 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
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
  1. Point-of-care CPR training
  2. Post-cardiac arrest educational debriefings
Other Name: ICU-RESUS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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%.



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Ages Eligible for Study:   37 Weeks to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 hospital admission did not occur in the ICU.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837497


Contacts
Contact: Carolann Twelves, RN BSN 2155904936 twelcesc@email.chop.edu
Contact: Mary Ann DiLiberto, BS RN 2674265753 diliberto@email.chop.edu

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Carolann Twelves, RN, BSN    215-590-4936    twelcesc@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Heart, Lung, and Blood Institute (NHLBI)
University of Utah
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Robert Sutton, MS MSCE Children's Hospital of Philadelphia

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02837497     History of Changes
Other Study ID Numbers: 15-012576
R01HL131544 ( U.S. NIH Grant/Contract )
UG1HD063108 ( U.S. NIH Grant/Contract )
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Children's Hospital of Philadelphia:
pediatric
heart arrest

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases