UMIN-CTR Clinical Trial

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