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Quality of Pediatric Resuscitation in a Multicenter Collaborative (pediRES-Q)

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: NCT02708134
Recruitment Status : Recruiting
First Posted : March 15, 2016
Last Update Posted : April 21, 2022
Sponsor:
Collaborator:
Zoll Medical Corporation
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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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
Cardiac Arrest Cardiopulmonary Arrest

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
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Study Type : Observational
Estimated 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 : March 2016
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Aggregate score composed of American Heart Association (AHA) recommended depth, rate, and chest compression fraction during CPR [ Time Frame: 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
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Ages Eligible for Study:   0 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Data will be collected from pediatric cardiac arrest events as part of standard clinical operations.
Criteria

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
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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): NCT02708134


Contacts
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Contact: Vinay Nadkarni, MD, MS 215-590-7430 nadkarni@chop.edu
Contact: Dana Niles 215-590-4039 niles@chop.edu

Locations
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United States, California
Cedars-Sinai Medical Center Not yet recruiting
Los Angeles, California, United States
Contact: Dipti Padhya, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Felice Su         
United States, Florida
All Children's Hospital Not yet recruiting
Saint Petersburg, Florida, United States
Contact: Ladonna Bingham, MD         
United States, Georgia
Children's Healthcare of Atlanta (CHOA) Recruiting
Atlanta, Georgia, United States
Contact: Katherine (Kat) Daniels, MLIS         
United States, Illinois
University of Chicago, Comer Children's Hospital Recruiting
Chicago, Illinois, United States, 60637
Contact: Priti Jani         
United States, New York
Albany Medical Center Recruiting
Albany, New York, United States
Contact: Ilana Harwayne-Gidansky, MD         
United States, Ohio
Akron Children's Recruiting
Akron, Ohio, United States
Contact: wendy Van Ittersum, MD         
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States
Contact: Maya Dewan         
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States
Contact: Tensing Maa         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Vinay Nadkarni, MD, MS    215-590-7430    nadkarni@chop.edu   
United States, South Carolina
Medical University of South Carolina Not yet recruiting
Charleston, South Carolina, United States
Contact: Allison Whalen, MD         
United States, Texas
Dell Children's Medical Center Recruiting
Austin, Texas, United States
Contact: Daniel Stromberg, MD         
University of Texas Southwestern Recruiting
Dallas, Texas, United States
Contact: Priscilla Yu, MD         
United States, Virginia
Children's Hospital of Richmond at VCU Recruiting
Richmond, Virginia, United States
Contact: Michelle Olson, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Joan Roberts         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Zoll Medical Corporation
Investigators
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Principal Investigator: Vinay Nadkarni, MD, MS Children's Hospital of Philadelphia
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT02708134    
Other Study ID Numbers: 15-012099
First Posted: March 15, 2016    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Children's Hospital of Philadelphia:
Chest compressions
Cardiopulmonary Resuscitation
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases