UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062856 |
|---|---|
| Receipt number | R000071747 |
| Scientific Title | Comparison of Pre-Shock Pause Times Among Defibrillator Models During Cardiopulmonary Resuscitation |
| Date of disclosure of the study information | 2026/09/09 |
| Last modified on | 2026/09/09 12:43:47 |
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Basic information
Public title
Comparison of Pre-Shock Pause Times Among Defibrillator Models During Cardiopulmonary Resuscitation
Acronym
Comparison of Pre-Shock Pause Times Among Defibrillator Models During Cardiopulmonary Resuscitation
Scientific Title
Comparison of Pre-Shock Pause Times Among Defibrillator Models During Cardiopulmonary Resuscitation
Scientific Title:Acronym
Comparison of Pre-Shock Pause Times Among Defibrillator Models During Cardiopulmonary Resuscitation
Region
| Japan |
Condition
Condition
Out-of-hospital cardiac arrest
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare the pre-shock pause time (PSPT) of three representative defibrillator models widely used in prehospital emergency medical services in Japan under a standardized protocol, and to provide scientific evidence to inform defibrillator selection in the EMS setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pre-shock Pause Time
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Simulation Experiment: Participants will undertake a 4-minute cardiac arrest simulation under a standardized protocol. Teams of three will be formed, with members assigned to the roles of defibrillator operator, ventilation provider, and chest compression provider. Each participant will rotate through all three roles and perform the simulation using each of the three defibrillator models. This crossover design will ensure that every participant completes all role-defibrillator combinations.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants will be paramedics employed by the Nagaoka Fire Department who understand the purpose of the study and voluntarily provide informed consent to participate.
Key exclusion criteria
Paramedics who do not provide informed consent to participate in the study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Takei |
Organization
Niigata University of Health and Welfare
Division name
Department of Emergency Medical Sciences
Zip code
9501398
Address
1398 Shimami, kita, Niigata city
TEL
+81252574644
yutaka-takei@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Takei |
Organization
Niigata University of Health and Welfare
Division name
Department of Emergency Medical Sciences
Zip code
9503198
Address
3198 Shimami, Kita, Niigata
TEL
+81252574644
Homepage URL
yutaka-takei@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Y Takei
Funding Source
Organization
Niigata University of Health and Welfare
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
the Ethics Committee of Niigata University of Health and Welfare
Address
3198 Shimami, Kita, Niigata
Tel
025-257-4455
yutaka-takei@nuhw.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
| 2026 | Year | 09 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 09 | Month | 09 | Day |
Last modified on
| 2026 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071747
