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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02708134
Registration number
NCT02708134
Ethics application status
Date submitted
28/01/2016
Date registered
15/03/2016
Titles & IDs
Public title
Quality of Pediatric Resuscitation in a Multicenter Collaborative
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Scientific title
Quality of Pediatric Resuscitation in a Multicenter Collaborative: An Observational Study
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Secondary ID [1]
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15-012099
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Universal Trial Number (UTN)
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Trial acronym
pediRES-Q
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiac Arrest
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Cardiopulmonary Arrest
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Aggregate score composed of American Heart Association (AHA) recommended depth, rate, and chest compression fraction during CPR
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Assessment method [1]
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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.
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Timepoint [1]
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10 Years
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Eligibility
Key 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
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Minimum age
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Years
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Maximum age
17
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patient on extracorporeal membrane oxygenation (ECMO) therapy at beginning of CPR event
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/05/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2030
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Actual
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Sample size
Target
5000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The Children's Hospital at Westmead - Westmead
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Delaware
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Florida
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Canada
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British Columbia
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Canada
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Calgary
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Singapore
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Taipei
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Hospital of Philadelphia
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Zoll Medical Corporation
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Address [1]
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02708134
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Trial related presentations / publications
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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Vinay Nadkarni, MD, MS
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Address
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Children's Hospital of Philadelphia
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Vinay Nadkarni, MD, MS
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Address
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Phone
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215-590-7430
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02708134