UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025684 |
|---|---|
| Receipt number | R000029206 |
| Scientific Title | Cerebral rSO2(regional saturation of oxygen) monitoring in cardiopulmonary arrest patients :non randomized prospective multicenter study |
| Date of disclosure of the study information | 2017/01/15 |
| Last modified on | 2021/09/29 11:37:39 |
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Basic information
Public title
Cerebral rSO2(regional saturation of oxygen) monitoring in cardiopulmonary arrest patients :non randomized prospective multicenter study
Acronym
Continuous Chest ComPression Resuscitation for 16 minutes: CCCPR16 study (tripleCPR16 study)
Scientific Title
Cerebral rSO2(regional saturation of oxygen) monitoring in cardiopulmonary arrest patients :non randomized prospective multicenter study
Scientific Title:Acronym
Continuous Chest ComPression Resuscitation for 16 minutes: CCCPR16 study (tripleCPR16 study)
Region
| Japan |
Condition
Condition
cardiopulmonary arrest patients on arrival at hospital
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine the efficacy of continuous chest compression eliminating every 2 minutes rhythm check for return of spontaneous circulation. The objects are more than 15 years old patients with cardiopulmonary arrest.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome: continuous chest compression results in the increase of return of spontaneous circulation.
Key secondary outcomes
Secondary outcome: Achievement of Target values of rSO2 under continuous chest compression is faster (10% increase in the group of more than 50% of initial mean rSO2 value, 20% increase in the group between 40 and 50 % of initial mean rSO2 value, 35% increase in the group less than 40% of initial rSO2 mean value) than conventional chest compression with 2 minutes interval rhythm check.
Thirtiary outcome: Adverse effect is not expected due to continuous chest compression for 16 minutes.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Continuous chest compression for 16 minutes and/or until achievement of the target cerebral rSO2 values.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with asystole or PEA for the initial rhythm on arrival at hospital
Key exclusion criteria
The patients with Vf or pVT for the initial rhythm on arrival at hospital
Target sample size
225
Research contact person
Name of lead principal investigator
| 1st name | Tadahiko |
| Middle name | |
| Last name | Shiozaki |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
5650871
Address
2-15 Yamada-oka, Suita, Osaka 565-0871 Japan
TEL
06-6879-5707
shiozaki@hp-emerg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuo |
| Middle name | |
| Last name | Ohnishi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Traumatology and Acute Critical Medicine
Zip code
5650871
Address
2-15 Yamada-oka, Suita, Osaka 565-0871 Japan
TEL
06-6879-5707
Homepage URL
mohnishi@hp-emerg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of raumatology and Acute Critical Medicine Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, culture, sports, science and technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Center for Translational Research Osaka University Hospital
Address
2-2, Yamada-oka, Suita, Osaka 565-0871 Japan
Tel
06-6210-8290
shiken@hp-crc.med.osaka-u.ac.jp
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
大阪大学医学部附属病院高度救命救急センター/Department of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine、関西医科大学附属病院高度救命救急センター/Department of Emergency and Critical Care Medicine, Kansai Medical University Hospital、関西医科大学総合医療センター救命救急センター/Department of Emergency and Critical Care Medicine, Kansai Medical University Medical Center
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
225
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029206
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