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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001675
Receipt No. 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

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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
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 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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002023

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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