UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061001 |
|---|---|
| Receipt number | R000069797 |
| Scientific Title | Development of a novel Augmented Reality (AR) educational tool for training in endotracheal intubation |
| Date of disclosure of the study information | 2026/03/24 |
| Last modified on | 2026/03/23 14:36:23 |
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Basic information
Public title
Development of a novel Augmented Reality (AR) educational tool for training in endotracheal intubation
Acronym
Development of a novel Augmented Reality (AR) educational tool for training in endotracheal intubation
Scientific Title
Development of a novel Augmented Reality (AR) educational tool for training in endotracheal intubation
Scientific Title:Acronym
Development of a novel Augmented Reality (AR) educational tool for training in endotracheal intubation
Region
| Japan |
Condition
Condition
Airway management
Classification by specialty
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop a novel educational tool for endotracheal intubation using augmented reality (AR) technology and to evaluate its effectiveness in skill acquisition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of endotracheal intubation. Defined as appropriate tracheal placement of the tube within 30 seconds of the start signal.
Key secondary outcomes
Qualitative data including procedural information and participants' feedback on the educational materials.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants in the intervention group will first learn the endotracheal intubation procedure using 2D instructional videos and printed materials, followed by guidance on equipment usage. Subsequently, they will receive direct instruction and engage in supplemental learning using a 3D AR model of endotracheal intubation.
Interventions/Control_2
Participants in the control group will learn the endotracheal intubation procedure using only 2D instructional videos and printed materials, followed by guidance on equipment usage.
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
Students in the MD (Doctor of Medicine) program at the Faculty of Medicine, The University of Tokyo
Key exclusion criteria
Individuals who must avoid external physical strain on the head and neck (e.g., those with a history of trauma or cervical spondylosis).
Individuals who have previously experienced motion sickness or physical discomfort when using AR or similar technologies.
Individuals with prior experience in performing endotracheal intubation procedures.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hisataka |
| Middle name | |
| Last name | Nozawa |
Organization
The University of Tokyo Hospital
Division name
Department of Pediatrics
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
nozawah-ped@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hisataka |
| Middle name | |
| Last name | Nozawa |
Organization
The University of Tokyo Hospital
Division name
Department of Pediatrics
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0338155411
Homepage URL
nozawah-ped@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Intensive Care Medicine
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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
0358410818
ethics@m.u-tokyo.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 | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
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
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 07 | 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 | 03 | Month | 21 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069797
