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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025684
Receipt No. 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 2019/07/22

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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
Email 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
Email mohnishi@hp-emerg.med.osaka-u.ac.jp

Sponsor
Institute Department of raumatology and Acute Critical Medicine Osaka University Graduate School of Medicine
Institute
Department

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
Email 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

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 15 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 Open public recruiting
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
2020 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
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029206

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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