pediRES-Q: Quality of Pediatric Resuscitation in a Multicenter Collaborative

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Recruiting
CT.gov ID
NCT02708134
Collaborator
Zoll Medical Corporation (Industry)
5,000
15
166
333.3
2

Study Details

Study Description

Brief Summary

This is a prospective, observational, multi-center cohort study of pediatric cardiac arrests.

The purpose of the study is to determine the association between chest compression mechanics (rate, depth, flow fraction, compression release) and patient outcomes. In addition, the investigators will determine the association of post cardiac arrest care with patient outcomes.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Cardiac arrests in children are a major public health problem. Thousands of children each year in the USA are treated with cardiopulmonary resuscitation (CPR) and managed after their cardiac arrest. Neurological outcomes following these in-hospital CPR events are often abnormal. As children with neurological deficits following CPR are a major burden for families and society, improving neurological outcomes through superior chest compression delivery during CPR and optimal care and management after cardiac arrest is an important clinical goal.

    Therefore, the objective of this investigation is to obtain evidentiary support to associate the relationship of quantitative CPR quality data (depth, rate, chest compressions (CC) fraction, compression release) during CPR, post-cardiac arrest care (PCAC) and patient survival in those children who suffer an arrest within the study (RES-Q) Network.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Quality of Pediatric Resuscitation in a Multicenter Collaborative: An Observational Study
    Study Start Date :
    Mar 1, 2016
    Anticipated Primary Completion Date :
    Jan 1, 2028
    Anticipated Study Completion Date :
    Jan 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Pediatric Cardiac Arrests

    Pediatric cardiac arrests requiring chest compressions for at least 1 minute managed at clinical centers identified as part of standard clinical operations.

    Outcome Measures

    Primary Outcome Measures

    1. Aggregate score composed of American Heart Association (AHA) recommended depth, rate, and chest compression fraction during CPR [10 Years]

      Primary outcome: "Guideline-compliant CPR" which will be determined by an aggregate score comprised of the following three components: depth, rate, and chest compression fraction. The three components will be analyzed in 30 and 60 second epochs. "Guideline-compliant CPR" requires that each component meet the following criteria: 1) Age-determined American Heart Association (AHA) guideline recommended depth; 2) rate ≥ 90 and ≤ 120 CC/min; and 3) CC Fraction ≥ 0.80. Depth, rate, and CC Fraction will be calculated for each epoch and an aggregate score will be assigned. The primary analysis will be performed on that total score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient received chest compressions for at least 1 minute

    • Patient between gestational age ≥37 weeks and 17 years of age

    • Patient had a quality of CPR measurements device (eg., Zoll Medical chest compression sensor) in place during chest compressions

    Exclusion Criteria:
    • Patient on extracorporeal membrane oxygenation (ECMO) therapy at beginning of CPR event

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cedars-Sinai Medical Center Los Angeles California United States
    2 Stanford University Palo Alto California United States 94304
    3 All Children's Hospital Saint Petersburg Florida United States
    4 Children's Healthcare of Atlanta (CHOA) Atlanta Georgia United States
    5 University of Chicago, Comer Children's Hospital Chicago Illinois United States 60637
    6 Albany Medical Center Albany New York United States
    7 Akron Children's Akron Ohio United States
    8 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States
    9 Nationwide Children's Hospital Columbus Ohio United States
    10 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    11 Medical University of South Carolina Charleston South Carolina United States
    12 Dell Children's Medical Center Austin Texas United States
    13 University of Texas Southwestern Dallas Texas United States
    14 Children's Hospital of Richmond at VCU Richmond Virginia United States
    15 Seattle Children's Hospital Seattle Washington United States 98105

    Sponsors and Collaborators

    • Children's Hospital of Philadelphia
    • Zoll Medical Corporation

    Investigators

    • Principal Investigator: Vinay Nadkarni, MD, MS, Children's Hospital of Philadelphia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Children's Hospital of Philadelphia
    ClinicalTrials.gov Identifier:
    NCT02708134
    Other Study ID Numbers:
    • 15-012099
    First Posted:
    Mar 15, 2016
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Children's Hospital of Philadelphia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 21, 2022