Clinical trial NCT02708134: Quality of Pediatric Resuscitation in a Multicenter Collaborative
Official title: Quality of Pediatric Resuscitation in a Multicenter Collaborative: An Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Cardiopulmonary Arrest
Keywords: Chest compressions
Cardiopulmonary Resuscitation
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Zoll Medical Corporation
First posted: 2016-03-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected from pediatric cardiac arrest events as part of standard clinical operations.

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.

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.

Eligibility 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

Primary outcomes:
measure: Aggregate score composed of American Heart Association (AHA) recommended depth, rate, and chest compression fraction during CPR
timeFrame: 10 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Orange
country: United States
facility: Chldren's Hospital of Orange County
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
city: Aurora
country: United States
facility: Children's Colorado
state: Colorado
city: Wilmington
country: United States
facility: Nemour's Children's Hopistal
state: Delaware
city: Saint Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta (CHOA)
state: Georgia
city: Chicago
country: United States
facility: Comer Children's Hospital
state: Illinois
city: Chicago
country: United States
facility: University of Chicago, Comer Children's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Stead Family Children's Hospital
state: Iowa
city: Lexington
country: United States
facility: Kentucky Children's Hospital
state: Kentucky
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's
state: Massachusetts
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Kravis Children's Hospital
state: New York
city: New York
country: United States
facility: Morgan Stanley Children's Hospital
state: New York
city: Queens
country: United States
facility: Cohen Children's Medical Center
state: New York
city: Syracuse
country: United States
facility: Upstate Golisano Children's Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Akron
country: United States
facility: Akron Children's
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Dell Children's Medical Center
state: Texas
city: Dallas
country: United States
facility: Medical City Children's Hospital
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Richmond
country: United States
facility: Children's Hospital of Richmond at VCU
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Westmead
country: Australia
facility: The Children's Hospital at Westmead
state: New South Wales
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Vancouver
country: Canada
facility: BC Children's
state: British Columbia
city: Calgary
country: Canada
facility: Alberta Children's
city: Bogotá
country: Colombia
facility: Instituto Roosevelt
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Children's Medical Center
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: KK Women's & Children's Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Vinay Nadkarni, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
citation: Raymond TT, Pandit SV, Griffis H, Zhang X, Hanna R, Niles DE, Silver A, Lasa JJ, Haskell SE, Atkins DL, Nadkarni VM; Pediatric Resuscitation Quality Collaborative (pediRES-Q) Investigators. Effect of Amplitude Spectral Area on Termination of Fibrillation and Outcomes in Pediatric Cardiac Arrest. J Am Heart Assoc. 2021 Jun 15;10(12):e020353. doi: 10.1161/JAHA.120.020353. Epub 2021 Jun 5.