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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039874
Receipt No. 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 2020/09/19

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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
Email 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
Email kobayashi.daisuke.2e@kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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 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
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
2020 Year 09 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045446

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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