UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021504 |
|---|---|
| Receipt number | R000024796 |
| Scientific Title | Quality of Pediatric Resuscitation in a Multicenter Collaborative: an Observational Study |
| Date of disclosure of the study information | 2016/03/18 |
| Last modified on | 2016/03/17 07:24:21 |
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Basic information
Public title
Quality of Pediatric Resuscitation in a Multicenter Collaborative: an Observational Study
Acronym
pedRES-Q
Scientific Title
Quality of Pediatric Resuscitation in a Multicenter Collaborative: an Observational Study
Scientific Title:Acronym
pedRES-Q
Region
| Japan | North America | Europe |
Condition
Condition
pediatric cardiac arrest
Classification by specialty
| Pediatrics | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Characterize the quality of CPR and post-cardiac arrest care delivered to children across a broad spectrum of hospitals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
"Guideline-compliant CPR", as analyzed by 30 and 60 second CPR echocs, and defined as epoch whose mean meets all of the following criteria: 1) Age-determined AHA guideline recommended depth; 2) rate 90-120 CC/min; and 3) CC fraction greater than 0.80
Key secondary outcomes
Secondary outcome will be the association of "Guideline-compliant CPR" and survival to hospital discharge will be include the following:
1) association of survival with site-specific post-cardiac arrest care
2) (Exploratory) association between ventilation rate and short-term patient survival
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patient (between gestational age older than 37 weeks old and 18 years old) received chest compressions for longer than 1 minute.
2. Patient between 37 weeks and 18 years of age
3. Patient had a quality of CPR measurement device (eg. ZOLL chest compression sensor) in place during chest compressions.
Key exclusion criteria
Patient on ECMO therapy at beginning of CPR event.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Vinay Nadkarni |
Organization
Children's Hospital of Philadelphia
Division name
Department of Anesthesia & Critical Care Medicine
Zip code
Address
34th Street and Civic Center Boulevard Philadelphia, PA, 19104-4399 USA
TEL
+1-215-590-7430
nadkarni@email.chop.edu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takanari Ikeyama |
Organization
Aichi Children's Health and Medical Center
Division name
Division of Pediatric Critical Care Medicine
Zip code
Address
7-426 Morioka-machi, Obu, Aichi JAPAN zip 474-8710
TEL
0562-43-0500
Homepage URL
taqnary@gmail.com
Sponsor or person
Institute
Children's Hospital of Philadelphia
Institute
Department
Personal name
Funding Source
Organization
Zoll Medical
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
あいち小児保健医療総合センター（愛知県）、都立小児総合医療センター（東京都）、金沢大学附属病院（石川県）、大阪医科大学付属病院（大阪府）、兵庫県立こども病院小児救急医療センター（兵庫県）他
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2015 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective, observational, multicenter cohort study of pediatric cardiac arrest management
Management information
Registered date
| 2016 | Year | 03 | Month | 17 | Day |
Last modified on
| 2016 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024796
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
