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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002061
Receipt No. R000002514
Scientific Title Effectiveness of mass training program of simplified chest compression-only CPR for the general public: Community intervention trial based on a large cohort
Date of disclosure of the study information 2009/06/30
Last modified on 2009/06/10

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Basic information
Public title Effectiveness of mass training program of simplified chest compression-only CPR for the general public: Community intervention trial based on a large cohort
Acronym Effectiveness of simplified chest compression-only CPR: Community intervention trial
Scientific Title Effectiveness of mass training program of simplified chest compression-only CPR for the general public: Community intervention trial based on a large cohort
Scientific Title:Acronym Effectiveness of simplified chest compression-only CPR: Community intervention trial
Region
Japan

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

Objectives
Narrative objectives1 To evaluate whether the spread of a mass training program of compression-only CPR can increase the proportion of bystander CPR and survival from out-of-hospital cardiac arrests.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Proportion of bystander CPR
Key secondary outcomes 1. Type of bystander CPR
2. VF as the initially recorded rhythm
3. AED use by the general public
4. Resuscitation time course
5. 1-month survival
6. Neurologically intact survival from witnessed OHCA of presumed cardiac etiology

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 The chest compression-only CPR group members were provided with a 45-minute mass training program consisting of continuous chest compressions and an AED operation.
Interventions/Control_2
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
11 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Citizens aged 11 years or more who live or work in the study area.
Key exclusion criteria Those who have physical disabilities to perform CPR or are considered to be unsuitable for CPR training.
Target sample size 56000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taku Iwam
Organization Kyoto University
Division name Health Service
Zip code
Address Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501
TEL 075-753-2401
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, 606-8501
TEL 075-753-2431
Homepage URL
Email c-nishi@st.pbh.med.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization The Laerdal foundation for acute Medicine
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Norway

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
2009 Year 06 Month 30 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
Date of protocol fixation
2009 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 06 Month 01 Day
Date trial data considered complete
2013 Year 12 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 10 Day
Last modified on
2009 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002514

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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