UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018117 |
|---|---|
| Receipt number | 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 13:34:41 |
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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
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
mineji@dream.com
Sponsor or person
Institute
Sapporo city fire department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020975
