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NCT02708134 Clinical Trial

Quality of Pediatric Resuscitation in a Multicenter Collaborative

Cardiac Arrest Clinical Trial

— pediRES-Q  

Official title:
Quality of Pediatric Resuscitation in a Multicenter Collaborative: An Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02708134
Other study ID # 15-012099
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 2, 2016
Est. completion date January 2030

Study information
Verified date April 2024
Source Children's Hospital of Philadelphia
Contact Vinay Nadkarni, MD, MS
Phone 215-590-7430
Email nadkarni@chop.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 5000
Est. completion date January 2030
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender All
Age group 0 Years to 17 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Australia The Children's Hospital at Westmead Westmead New South Wales
Canada Alberta Children's Calgary
Canada Stollery Children's Hospital Edmonton Alberta
Canada BC Children's Vancouver British Columbia
Colombia Instituto Roosevelt Bogotá
Japan Tokyo Metropolitan Children's Medical Center Tokyo
Singapore KK Women's & Children's Hospital Singapore
Singapore National University Hospital Singapore
Taiwan National Taiwan University Hospital Taipei
United Kingdom Great Ormond Street Hospital London
United States Akron Children's Akron Ohio
United States Albany Medical Center Albany New York
United States Children's Healthcare of Atlanta (CHOA) Atlanta Georgia
United States Children's Colorado Aurora Colorado
United States Dell Children's Medical Center Austin Texas
United States The Johns Hopkins Hospital Baltimore Maryland
United States Boston Children's Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of North Carolina Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States Comer Children's Hospital Chicago Illinois
United States University of Chicago, Comer Children's Hospital Chicago Illinois
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States Medical City Children's Hospital Dallas Texas
United States University of Texas Southwestern Dallas Texas
United States Riley Hospital for Children Indianapolis Indiana
United States University of Iowa Stead Family Children's Hospital Iowa City Iowa
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Kentucky Children's Hospital Lexington Kentucky
United States Cedars-Sinai Medical Center Los Angeles California
United States Kaiser Permanente Los Angeles California
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Morgan Stanley Children's Hospital New York New York
United States Mount Sinai Kravis Children's Hospital New York New York
United States Nebraska Medical Center Omaha Nebraska
United States Chldren's Hospital of Orange County Orange California
United States Stanford University Palo Alto California
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States Cohen Children's Medical Center Queens New York
United States Children's Hospital of Richmond at VCU Richmond Virginia
United States St. Louis Children's Hospital Saint Louis Missouri
United States All Children's Hospital Saint Petersburg Florida
United States Rady Children's Hospital San Diego California
United States Seattle Children's Hospital Seattle Washington
United States Seattle Children's Hospital Seattle Washington
United States Upstate Golisano Children's Hospital Syracuse New York
United States Nemour's Children's Hopistal Wilmington Delaware

Sponsors (2)
Lead Sponsor Collaborator
Children's Hospital of Philadelphia Zoll Medical Corporation

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Colombia,  Japan,  Singapore,  Taiwan,  United Kingdom, 

References & Publications (5)

Esangbedo I, Yu P, Raymond T, Niles DE, Hanna R, Zhang X, Wolfe H, Griffis H, Nadkarni V; Pediatric Resuscitation Quality (pediRES-Q) Collaborative Investigators. Pediatric in-hospital CPR quality at night and on weekends. Resuscitation. 2020 Jan 1;146:56-63. doi: 10.1016/j.resuscitation.2019.10.039. Epub 2019 Nov 14. — View Citation

Niles DE, Duval-Arnould J, Skellett S, Knight L, Su F, Raymond TT, Sweberg T, Sen AI, Atkins DL, Friess SH, de Caen AR, Kurosawa H, Sutton RM, Wolfe H, Berg RA, Silver A, Hunt EA, Nadkarni VM; pediatric Resuscitation Quality (pediRES-Q) Collaborative Investigators. Characterization of Pediatric In-Hospital Cardiopulmonary Resuscitation Quality Metrics Across an International Resuscitation Collaborative. Pediatr Crit Care Med. 2018 May;19(5):421-432. doi: 10.1097/PCC.0000000000001520. — View Citation

Pfeiffer S, Lauridsen KG, Wenger J, Hunt EA, Haskell S, Atkins DL, Duval-Arnould JM, Knight LJ, Cheng A, Gilfoyle E, Su F, Balikai S, Skellett S, Hui MY, Niles DE, Roberts JS, Nadkarni VM, Tegtmeyer K, Dewan M; Pediatric Resuscitation Quality Collaborative Investigators. Code Team Structure and Training in the Pediatric Resuscitation Quality International Collaborative. Pediatr Emerg Care. 2021 Aug 1;37(8):e431-e435. doi: 10.1097/PEC.0000000000001748. — View Citation

Sweberg T, Sen AI, Mullan PC, Cheng A, Knight L, Del Castillo J, Ikeyama T, Seshadri R, Hazinski MF, Raymond T, Niles DE, Nadkarni V, Wolfe H; pediatric resuscitation quality (pediRES-Q) collaborative investigators. Description of hot debriefings after in-hospital cardiac arrests in an international pediatric quality improvement collaborative. Resuscitation. 2018 Jul;128:181-187. doi: 10.1016/j.resuscitation.2018.05.015. Epub 2018 May 26. — View Citation

Wolfe HA, Wenger J, Sutton R, Seshadri R, Niles DE, Nadkarni V, Duval-Arnould J, Sen AI, Cheng A. Cold Debriefings after In-hospital Cardiac Arrest in an International Pediatric Resuscitation Quality Improvement Collaborative. Pediatr Qual Saf. 2020 Jul 8;5(4):e319. doi: 10.1097/pq9.0000000000000319. eCollection 2020 Jul-Aug. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Aggregate score composed of American Heart Association (AHA) recommended depth, rate, and chest compression fraction during CPR 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. 10 Years
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