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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018117
Receipt No. R000020975
Scientific Title Effect of feedback by NIRO-CCR1 during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest
Date of disclosure of the study information 2015/06/28
Last modified on 2016/06/30

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Basic information
Public title Effect of feedback by NIRO-CCR1 during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest
Acronym Effect of feedback by NIRO-CCR1 during CPR for OHCA patients
Scientific Title Effect of feedback by NIRO-CCR1 during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Mineji Hayakawa
Organization Hokkaido University Hospital
Division name Emergency and Critical Care Center
Zip code
Address N14W5, kita-Ku, Sapporo, 060-8648, Japan
TEL 011-706-7377
Email mineji@dream.com

Public contact
Name of contact person
1st name
Middle name
Last name Mineji Hayakawa
Organization Hokkaido University Hospital
Division name Emergency and Critical Care Center
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2015 Year 06 Month 23 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020975

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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