UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001675 |
|---|---|
| Receipt number | R000002023 |
| Scientific Title | Effectiveness of mass training program of chest compression-only CPR using a personal manikin: a randomized controlled trial. |
| Date of disclosure of the study information | 2009/01/31 |
| Last modified on | 2014/08/07 14:34:34 |
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Basic information
Public title
Effectiveness of mass training program of chest compression-only CPR using a personal manikin: a randomized controlled trial.
Acronym
Effectiveness of mass training program of chest compression-only CPR.
Scientific Title
Effectiveness of mass training program of chest compression-only CPR using a personal manikin: a randomized controlled trial.
Scientific Title:Acronym
Effectiveness of mass training program of chest compression-only CPR.
Region
| Japan |
Condition
Condition
Cardiac arrest
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the 45-min mass training program of chest compression-only CPR using a personal manikin with the conventional 180-min CPR training program where both chest compressions and rescue breathing were taught.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1.The net number of appropriate chest compressions performed during two-minute test period six month after the training.
2.Proportion calculated as the actual number of appropriate chest compressions over the theoretically attainable number based on a CPR guideline.
Key secondary outcomes
1.CPR performances and their attitudes toward CPR six month after the training.
2.CPR performances and their attitudes toward CPR one year after the training.
3.Attitudes toward CPR before and immediately after the CPR training.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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 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
The conventional CPR group members were provided with a 180-minute training program consisting of chest compressions, mouth-to-mouth ventilations, 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 or more living in Japan.
Key exclusion criteria
1. Healthcare professionals (medical doctor, nurse, pharmacist, nutritionist, medical technician, radiographer, occupational therapist, physical therapist, medical engineer, and paramedic)
2. Students majoring healthcare.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taku Iwami |
Organization
Kyoto University
Division name
Health Service
Zip code
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto, 606-8501
TEL
075-753-2401
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
c-nishi@st.pbh.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Health and Labour Sciences Research Grants (H18-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
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 | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2008 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 31 | Day |
Last modified on
| 2014 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002023
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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