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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030577
Receipt No. R000034914
Scientific Title Development of simplified CPR training program and verification of effect using CPR simulator with real time feedback function.
Date of disclosure of the study information 2017/12/26
Last modified on 2018/12/27

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Basic information
Public title Development of simplified CPR training program and verification of effect using CPR simulator with real time feedback function.
Acronym Simplified CPR training program development
Scientific Title Development of simplified CPR training program and verification of effect using CPR simulator with real time feedback function.
Scientific Title:Acronym Simplified CPR training program development
Region
Japan

Condition
Condition A nurse working in a hospital
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of a CPR training program that can be implemented in a short time and verifying the effectiveness of the program.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Each score after CPR training
1.depth of chest compressions
2.release of chest compressions
3.chest compressive rhythm
4.ventilation volume using bag valve mask
5.chest compressive interruption time for ventilation
Key secondary outcomes Confidence and understanding of implementation of CPR procedure
Knowledge on CPR procedure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Intervention group
Implement simplifed CPR training using a simulator with real time feedback function.
Intervention time is about 15 minutes.
Technical evaluation of 5 minutes before and after intervention.
Technical evaluation of 5 minutes after 6 months.
Interventions/Control_2 Control group 1
Waiting list control group: Implement simple CPR training 6 months later.
Interventions/Control_3 Control group 2
Conventional education program implemented.
Intervention time is about 90 minutes
Technical evaluation of 5 minutes before and after intervention.
Technical evaluation of 5 minutes after 6 months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Nurse who worked at the research hospital and agreed to participate in the research.
Key exclusion criteria Those who received CPR training during the past 6 months.
Target sample size 320

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Kgaya
Organization Tohoku University Graduate School of Medicine
Division name Office of Medical Education
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-8508
Email kagaya@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nozomu Takada
Organization Tohoku University Graduate School of Medicine
Division name Office of Medical Education
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-8508
Homepage URL
Email takada@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2017 Year 12 Month 26 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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 26 Day
Last modified on
2018 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034914

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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