UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054840 |
|---|---|
| Receipt number | R000062663 |
| Scientific Title | Impact of Possessing Cardiac Arrest Recognition Assistance Devices on Citizen Response to Cardiac Arrest: A Randomized Controlled Trial. |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/07/01 12:12:29 |
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Basic information
Public title
Impact of Possessing Cardiac Arrest Recognition Assistance Devices on Citizen Response to Cardiac Arrest: A Study on Psychological Barriers.
Acronym
Impact of Possessing Cardiac Arrest Recognition Assistance Devices on Citizen Response to Cardiac Arrest.
Scientific Title
Impact of Possessing Cardiac Arrest Recognition Assistance Devices on Citizen Response to Cardiac Arrest: A Randomized Controlled Trial.
Scientific Title:Acronym
Impact of Possessing Cardiac Arrest Recognition Assistance Devices on Citizen Response to Cardiac Arrest.
Region
| Japan |
Condition
Condition
Cardiac arrest
Classification by specialty
| Cardiology | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare non-medical individuals with and without a cardiac arrest recognition assistance device (pulse checker) to evaluate whether possession of such a device can reduce psychological barriers in recognizing cardiac arrest when encountering a collapsed individual.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in psychological barriers to cardiopulmonary resuscitation before and after intervention using the VAS scale.
Key secondary outcomes
Psychological barriers before and after the intervention other than the primary outcome, confidence in specific cardiopulmonary resuscitation actions before and after the intervention, psychological barriers and specific cardiopulmonary resuscitation actions when using the pulse checker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions: At the start of the shift, individuals receive a document summarizing the procedure for cardiopulmonary resuscitation (CPR), which includes the necessity of checking for breathing to determine cardiac arrest, and receive an explanation about it. Additionally, they are instructed on how to use the pulse checker and carry it during the same shift.
Interventions/Control_2
Control: At the start of the shift, individuals receive a document summarizing the procedure for CPR, which includes the necessity of checking for breathing to determine cardiac arrest, and receive an explanation about it.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 and older who do not hold a national medical qualification, are involved in working or managing events at convention centers or stadiums, and possess a smartphone or PC for responding to web questionnaires.
Key exclusion criteria
None.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University
Division name
Department of Preventive Services, School of Public Health, Graduate School of Medicine
Zip code
606-8501
Address
Yoshidahonmachi,Sakyo-ku kyoto-shi, Kyoto
TEL
075-753-4400
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryuta |
| Middle name | |
| Last name | Onodera |
Organization
Kyoto University
Division name
Department of Preventive Services, School of Public Health, Graduate School of Medicine
Zip code
606-8501
Address
Yoshidahonmachi,Sakyo-ku kyoto-shi, Kyoto
TEL
075-753-4400
Homepage URL
onodera.ryuta.37v@st.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Preventive Services, School of Public Health, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
NIHON KOHDEN CORPORATION
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
Yoshidakonoe-cho, Sakyo-ku, Kyoto City
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
| 2024 | Year | 07 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 01 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062663
