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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000321
Receipt No. R000000414
Scientific Title A randomized controlled trial of the effectiveness of simplified CPR education for the general public.
Date of disclosure of the study information 2006/02/03
Last modified on 2006/08/18

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Basic information
Public title A randomized controlled trial of the effectiveness of simplified CPR education for the general public.
Acronym RCT of simplified CPR education.
Scientific Title A randomized controlled trial of the effectiveness of simplified CPR education for the general public.
Scientific Title:Acronym RCT of simplified CPR education.
Region
Japan

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

Objectives
Narrative objectives1 The study aims to investigate whether education of simplified CPR limited to chest compression and AED operation prompts appropriate cardiac massage compared with standard CPR(ventilation,chest compression,and AED operation)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Ratio of the number of chest compression appropriately performed during 2 minutes to theoretical value.
Key secondary outcomes 1.Number of chest compression per minute 2.Number of appropriate chest compression per minute 3.Proportion of appropriate chest compression per minute
4.Interruption time of chest compression 5.Time to first chest compression 6.Average depth and velocity of compression 7.Time to first AED discharge 8.Number and volume of ventilation per minute 9.Number of appropriate ventilation 10.Time to first ventilation

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_1 180-minute education of standard CPR consisting of chest compression, ventilation, and AED operation.
Interventions/Control_2 120-minute education of simplified CPR consisting of chest compression and 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

Not applicable
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,nutritionist,medical technician,radiographer,occupational therapist,physical therapist,medical engnerr,paramedic)
2.Students majoring healthcare
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kawamura
Organization Kyoto University
Division name Kyoto University Health Service
Zip code
Address Yoshida-honmachi,Sakyo-ku,Kyoto
TEL 075-753-2400
Email

Public contact
Name of contact person
1st name
Middle name
Last name Chika Nishiyama
Organization Kyoto University
Division name Department of Preventive Services,Kyoto University School of Public Health
Zip code
Address Yoshida-honmachi,Sakyo-ku,Kyoto
TEL
Homepage URL
Email chikabom@st.pbh.med.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japanese Population-based Utstein-styled study with basic and advanced Life Support Education.
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Cardiovascular Center
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
2006 Year 02 Month 03 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
2005 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2006 Year 01 Month 01 Day
Last follow-up date
2006 Year 07 Month 01 Day
Date of closure to data entry
2006 Year 08 Month 01 Day
Date trial data considered complete
2006 Year 08 Month 01 Day
Date analysis concluded
2007 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 02 Month 03 Day
Last modified on
2006 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000414

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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