UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030577 |
|---|---|
| Receipt number | 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 | 2023/01/25 16:15:40 |
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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
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
takada@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 26 | Day |
Last modified on
| 2023 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034914
