UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prehospital Resuscitation for Sustaining cerebral Oxidation: observational cohort study
Title of the study (Brief title)	Prehospital Resuscitation for Sustaining cerebral Oxidation: observational cohort study
Region	Japan

Condition
Condition	Out of hospital cardiac arrest
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the capability of regional brain oxygen saturation (rSO2) obtained in ambulance car by EMS to predict neurological outcomes in patients after out-of hospital cardiac arrest.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CPC (Glasgow-Pittsburgh Cerebral Performance Categories) at 90 days after out-of hospital cardiac arrest.
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with cardiac arrest on arrival after out-of hospital cardiac arrest, or patients with return to spontaneous circulation and comatose on arrival after out-of hospital cardiac arrest
Key exclusion criteria	Out-of hospital cardiac arrest from a traumatic origin with uncontrolled bleeding, or patients with previous completion of a <Do Not Attempt Resuscitation> form
Target sample size	100

Research contact person
Name of lead principal investigator	Kei Nishiyama
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Primary Care and Emergency Medicine
Address	54 Kawahara-chou, Shogoin, Sakyo-ku, 606-8507 Japan
TEL	075-751-3126
Email	keinishi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Kei Nishiyama
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Primary Care and Emergency Medicine
Address	54 Kawahara-chou, Shogoin, Sakyo-ku, 606-8507 Japan
TEL	075-751-3126
Homepage URL
Email	keinishi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Japan Covidien Co. Ltd

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 02 Month 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 09 Month 10 Day
Anticipated trial start date	2015 Year 03 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	observational study

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2019 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030069