UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059566 |
|---|---|
| Receipt number | R000067934 |
| Scientific Title | Effect of Anesthesia Simulation Training Using a 3D-Printed Tracheal Model with Esophageal Atresia : A Pre-Post Study |
| Date of disclosure of the study information | 2025/10/28 |
| Last modified on | 2025/10/28 13:57:46 |
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Basic information
Public title
Effect of Anesthesia Simulation Training Using a 3D-Printed Tracheal Model with Esophageal Atresia : A Pre-Post Study
Acronym
EA-Sim Study
Scientific Title
Effect of Anesthesia Simulation Training Using a 3D-Printed Tracheal Model with Esophageal Atresia : A Pre-Post Study
Scientific Title:Acronym
EA-Sim Study
Region
| Japan |
Condition
Condition
Not applicable (Educational study targeting anesthesiologists, not patients
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study evaluate the effectiveness of simulation-based training using a 3D-printed tracheal model with esophageal atresia to help anesthesiologists acquire the skills for tracheoesophageal fistula closure and neonatal airway management. The educational effectiveness of this program will be evaluated in terms of improvement in technical performance and self-efficacy. Demonstrating the usefulness of this 3D model-based simulation training may contribute to enhancing specialized anesthesia education, supplementing limited clinical opportunities, improving residents' technical skills, and ultimately promoting patient safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Global Rating Scale (total score: 35 points) before and after the simulation-based training
Key secondary outcomes
Specific Checklist (10-point scale; maximum score = 10)
Time required (seconds)
Self-Efficacy Questionnaire (7 items; each item scored 0-100)
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
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Simulation-based education will be conducted using a 3D-printed tracheal model simulating esophageal atresia with tracheoesophageal fistula.
The educational program consists of three stages:
Didactic lecture (about 15 min): Explanation of the anatomy relevant to tracheoesophageal fistula closure, anesthesia management, and procedural overview.
Hands-on training (about 30 min): Small-group instruction with a 1:2 instructor-to-trainee ratio using the 3D-printed airway model.
Assessment (before and after hands-on training): Participants perform balloon-catheter closure of the tracheoesophageal fistula; procedures are video recorded. Two blinded assessors grade the recordings using the Global Rating Scale (maximum score 35).
Educational effect will be analyzed by comparing evaluation scores before vs. after the hands-on training.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Anesthesiologists who have no prior clinical experience in tracheoesophageal fistula closure using a balloon catheter
Able to participate in the educational program during the study period
Provided written informed consent after receiving a full explanation of the study
Key exclusion criteria
Individuals who declined to provide written informed consent
Those who have previously participated in similar tracheoesophageal fistula closure training
Those unable to participate in the educational program during the study period
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Hara |
Organization
Matsudo City General Hospital
Division name
Department of Anesthesiology
Zip code
2702296
Address
993-1 Sendabori, Matsudo City, Chiba Prefecture
TEL
0477122511
tkkhrtkd-anes@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Hara |
Organization
Matsudo City General Hospital
Division name
Department of Anesthesiology
Zip code
2702296
Address
993-1 Sendabori, Matsudo City, Chiba Prefecture
TEL
0477122511
Homepage URL
tkkhrtkd-anes@yahoo.co.jp
Sponsor or person
Institute
Matsudo City General Hospital
Institute
Department
Personal name
Funding Source
Organization
NONE
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsudo City General Hospital
Address
Matsudo City General Hospital
Tel
0477122511
tkkhrtkd-anes@yahoo.co.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
松戸市立総合医療センター
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 28 | 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
| 2025 | Year | 09 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067934
