UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of feedback by NIRO-CCR1 during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest
Title of the study (Brief title)	Effect of feedback by NIRO-CCR1 during CPR for OHCA patients
Region	Japan

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

Objectives
Narrative objectives1	To assess the quality of CPR by emergency medical services and the effects of feedback by NIRO-CCR1 during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Rate of return of spontaneous circulation
Key secondary outcomes	Survival rate Rate of favorable neurological outcome Relationships between parameters of NIRO-CCR1 and outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Monitoring by NIRO-CCR1 during cardiopulmonary resuscitation by emergency medical services
Interventions/Control_2	No monitoring by NIRO-CCR1 during cardiopulmonary resuscitation by emergency medical services
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	OHCA patients performed CPR by emergency medical services in Sapporo
Key exclusion criteria	OHCA by trauma
Target sample size	700

Research contact person
Name of lead principal investigator	Mineji Hayakawa
Organization	Hokkaido University Hospital
Division name	Emergency and Critical Care Center
Address	N14W5, kita-Ku, Sapporo, 060-8648, Japan
TEL	011-706-7377
Email	mineji@dream.com

Public contact
Name of contact person	Mineji Hayakawa
Organization	Hokkaido University Hospital
Division name	Emergency and Critical Care Center
Address	N14W5, kita-Ku, Sapporo, 060-8648, Japan
TEL	011-706-7377
Homepage URL
Email	mineji@dream.com

Sponsor
Institute	Sapporo city fire department
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Foundation for Ambulance Service Development in Japan.
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 06 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 23 Day
Anticipated trial start date	2015 Year 07 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 28 Day
Last modified on	2016 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020975