UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062855 |
|---|---|
| Receipt number | R000071311 |
| Scientific Title | A Randomized Crossover Simulation Study of Pre-shock Pause Time Across Different Defibrillator Models |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/09 12:42:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of Pre-shock Pause Duration Across Different Defibrillator Models
Acronym
Comparison of Pre-shock Pause Duration Across Different Defibrillator Models
Scientific Title
A Randomized Crossover Simulation Study of Pre-shock Pause Time Across Different Defibrillator Models
Scientific Title:Acronym
A Randomized Crossover Simulation Study of Pre-shock Pause Time Across Different Defibrillator Models
Region
| Japan |
Condition
Condition
Patients with cardiac arrest
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to compare pre-shock pause time (PSPT) across three representative defibrillator models commonly used in Japanese prehospital emergency care using a standardized protocol, and to generate evidence to support evidence-based defibrillator selection in emergency medical services.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interruption time for chest compressions
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Simulation Experiment: Each participant will take part in a simulation experiment lasting approximately 1 hour. A 4-minute cardiac arrest simulation scenario will be conducted with three participants per group, assigned to the roles of defibrillator operator, ventilation provider, and chest compression provider.
Using a randomized crossover design, all participants will perform each role with each of the three defibrillator models under evaluation. Consequently, each group will complete a total of nine simulation trials (three defibrillator models three roles).
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Paramedic working at fire station
Key exclusion criteria
Individuals who do not agree with the purpose of 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
950-3198
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 Universiy 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
新潟県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | 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
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=R000071311
