UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063231 |
|---|---|
| Receipt number | R000072333 |
| Scientific Title | Development and Prospective Evaluation of a Simulation-Based Team Training Program for Critical Events in the Pediatric Intensive Care Unit |
| Date of disclosure of the study information | 2026/10/13 |
| Last modified on | 2026/10/08 23:24:25 |
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Basic information
Public title
Development and Prospective Evaluation of a Simulation-Based Team Training Program for Critical Events in the Pediatric Intensive Care Unit
Acronym
PICU-SIM
Scientific Title
Development and Prospective Evaluation of a Simulation-Based Team Training Program for Critical Events in the Pediatric Intensive Care Unit
Scientific Title:Acronym
PICU-SIM
Region
| Japan |
Condition
Condition
Congenital heart disease, cardiac arrest, and conditions requiring mechanical ventilation
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively evaluate, in a simulated environment, the impact of a PICU-specific simulation-based educational program on integrated recognition of critical illness based on physiological monitor data, critical action performance, and team performance during pediatric intensive care emergencies.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Descriptive statistics will be used to summarize the primary outcome, the Critical Action Score. Differences according to participant characteristics, scenario type, and team composition will be explored as exploratory analyses. If repeated measurements are obtained, data will be analyzed using a mixed-effects model.
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
| Behavior,custom |
Interventions/Control_1
The intervention in this study consists of simulation-based education using scenarios developed to reflect clinical situations specific to the pediatric intensive care unit (PICU).
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
doctors working in PICU at National center for child health and development
nurses working in PICU at National center for child health and development
Key exclusion criteria
Individuals who do not consent to participate in the study.
Individuals deemed unsuitable for participation, including those unable to complete the study protocol because their ICU training placement is too short.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Kubota |
Organization
National center for child health and development
Division name
Division of critical care medicine
Zip code
157-8535
Address
2-10-1 Okura,Setagaya-ku,Tokyo
TEL
03-3416-0181
kubota-h@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Kubota |
Organization
National center for child health and development
Division name
Division of critical care medicine
Zip code
157-8535
Address
2-10-1 Okura,Setagaya-ku,Tokyo
TEL
03-3418-0181
Homepage URL
kubota-h@ncchd.go.jp
Sponsor or person
Institute
National center for child health and development
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National center for child health and development
Address
2-10-1 Okura,Setagaya-ku,Tokyo
Tel
03-3418-0181
kubota-h@ncchd.go.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 | 10 | Month | 13 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2028 | 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 | 10 | Month | 09 | Day |
Last modified on
| 2026 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072333
