Quality of Pediatric Resuscitation in a Multicenter Collaborative

Overview

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.

Full Title of Study: “Quality of Pediatric Resuscitation in a Multicenter Collaborative: An Observational Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2028

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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 0 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Philadelphia
  • Collaborator
    • Zoll Medical Corporation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Vinay Nadkarni, MD, MS, Principal Investigator, Children’s Hospital of Philadelphia
  • Overall Contact(s)
    • Vinay Nadkarni, MD, MS, 215-590-7430, nadkarni@chop.edu

References

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.

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.

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.