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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007933
Receipt No. 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

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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
Email

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
Email mineji@dream.com

Sponsor
Institute Sapporo Fire Bureau
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 Japan

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009335

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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