UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000321 |
|---|---|
| Receipt number | 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 15:09:04 |
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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
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
chikabom@st.pbh.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000414
