UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039874 |
|---|---|
| Receipt number | R000045446 |
| Scientific Title | A study on the change of perception of cardiac arrest and behavioral barriers by using a cardiac arrest recognition device in the general public |
| Date of disclosure of the study information | 2020/05/07 |
| Last modified on | 2024/04/02 18:54:42 |
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Basic information
Public title
A study on the change of perception of cardiac arrest and behavioral barriers by using a cardiac arrest recognition device in the general public
Acronym
The change of perception of cardiac arrest and behavioral barriers by using a cardiac arrest recognition device
Scientific Title
A study on the change of perception of cardiac arrest and behavioral barriers by using a cardiac arrest recognition device in the general public
Scientific Title:Acronym
The change of perception of cardiac arrest and behavioral barriers by using a cardiac arrest recognition device
Region
| Japan |
Condition
Condition
Healthy adult citizens who work in places where sudden cardiac arrest is expected
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether general citizen can recognize cardiac arrest early and reduce psychological barriers for determining cardiac arrest, by using the cardiac arrest recognition device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological barriers to lifesaving before and after possession of the cardiac arrest recognition device, and confidence in cardiopulmonary resuscitation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
possession of the cardiac arrest recognition device
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Adult general citizens who work in places where sudden cardiac arrest is expected
(2) Over 20 years old
(3) After the informed consent is sufficient for participation in this study, the study subject's own approval has been obtained.
Key exclusion criteria
citizens who have national medical qualification
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Health Service
Zip code
606-8501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2426
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kobayashi |
Organization
Kyoto University
Division name
Health Service
Zip code
606-8501
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
TEL
075-753-2426
Homepage URL
kobayashi.daisuke.2e@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Nihon Kohden Corp.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Honmachi, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
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
| 2020 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2020 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045446
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
