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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004101
Receipt No. R000004810
Scientific Title Effectiveness of simplified refresher CPR training with chest compression-only CPR : a randomized controlled trial
Date of disclosure of the study information 2010/08/25
Last modified on 2012/09/26

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Basic information
Public title Effectiveness of simplified refresher CPR training with chest compression-only CPR : a randomized controlled trial
Acronym Effectiveness of simplified refresher CPR training program
Scientific Title Effectiveness of simplified refresher CPR training with chest compression-only CPR : a randomized controlled trial
Scientific Title:Acronym Effectiveness of simplified refresher CPR training program
Region
Japan

Condition
Condition Cardiac arrest
Classification by specialty
Cardiology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compared the CPR skills one year after the training between those with and without the refresher CPR training.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome measures is the net number of appropriate chest compressions performed during two-minute test period one year after the training
Key secondary outcomes One year after the training
1.Check consciousness
2.Call for help
3.Call for AED
4.Time to first chest compression
5. Number of chest compressions during two-minute test period
6. Number of chest compressions with appropriate depth during two-minute test period
7. Number of chest compressions with correct hand position during two-minute test period
8. Number of chest compressions with appropriate recoil during two-minute test period
9.Time without chest compressions
10.Tune on AED
11.Correct positioning of defibrillator pad
12.clear self and area
13. Time to first AED defibrillator
14. Awareness of CPR and AED use

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 The refresher training course group members were given a 45-minute training program consisting of continuous chest compressions and an AED operation and 15-minute refresher training course after 6 month.
Interventions/Control_2 The control group members were given a 45-minute training program consisting of continuous chest compressions and an AED operation.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria General public 18 years of age or older living in Japan.
Key exclusion criteria 1.Healthcare professionals(medical doctor nurse pharmacist,medicaltechnician,radiografher,occupational thrapist,physical therapist,medical engineer,paramedic)
2.Students majoring healthcare
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Iwami Taku
Organization Kyoto University
Division name Health service
Zip code
Address Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501
TEL 075-753-2431
Email

Public contact
Name of contact person
1st name
Middle name
Last name Okamoto Yoshio
Organization Okayama University
Division name Pediatrics
Zip code
Address Shikata-cho. Kita-ku,Okayama.700-8558
TEL 086-2325-6643
Homepage URL
Email

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Grant-in-Aid for Health and Labour Sciences Research Grants (H21-Shinkin-001) from the Ministry of Health, Labour and Welfare.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kyoto University
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 京都大学  Kyoto University

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 25 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
2010 Year 08 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 06 Month 01 Day
Date trial data considered complete
2012 Year 09 Month 01 Day
Date analysis concluded
2012 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 08 Month 25 Day
Last modified on
2012 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004810

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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