UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007933 |
|---|---|
| Receipt number | R000009335 |
| Scientific Title | Effectiveness of chest compression for patients with out-of-hospital cardiac arrest |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2013/05/23 07:09:32 |
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Basic information
Public title
Effectiveness of chest compression for patients with out-of-hospital cardiac arrest
Acronym
Effectiveness of chest compression for patients with out-of-hospital cardiac arrest
Scientific Title
Effectiveness of chest compression for patients with out-of-hospital cardiac arrest
Scientific Title:Acronym
Effectiveness of chest compression for patients with out-of-hospital cardiac arrest
Region
| Japan |
Condition
Condition
out-of-hospital cardiac arrest
Classification by specialty
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess peripheral circulation during cardiopulmonary resuscitation for patients with out-of-hospital cardiac arrest by RAD-57. (Masimo Corporation, Tokyo, Japan)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of return of spontaneous circulation
Key secondary outcomes
Perfusion index measured by RAD-57 during CPR
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
1. Training to use RAD-57 for 2 weeks.
2. Cardiopulmonary resuscitation with monitoring the perfusion index of RAD-57 for out-of-hospital cardiac arrest for 3.5 months
3. 2 weeks interval
4. Cardiopulmonary resuscitation without monitoring the perfusion index of RAD-57 for out-of-hospital cardiac arrest for 3.5 months
Interventions/Control_2
1. 2 weeks interval
2. Cardiopulmonary resuscitation without monitoring the perfusion index of RAD-57 for out-of-hospital cardiac arrest for 3.5 months
3. Training to use RAD-57 for 2 weeks.
4. Cardiopulmonary resuscitation with monitoring the perfusion index of RAD-57 for out-of-hospital cardiac arrest for 3.5 months
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
out-of-hospital cardiac arrest patients with bystander witness.
Key exclusion criteria
traumatic cardiac arrest
Target sample size
400
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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hokkaido University Hospital
Division name
Emergency and Critical Care Center
Zip code
Address
TEL
Homepage URL
mineji@dream.com
Sponsor or person
Institute
Sapporo Fire Bureau
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
Japan
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
| 2012 | Year | 06 | Month | 01 | 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
| 2011 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
| 2012 | Year | 05 | Month | 11 | Day |
Last modified on
| 2013 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009335
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
