UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062053 |
|---|---|
| Receipt number | R000070579 |
| Scientific Title | A Study on the Effects of Intubation Training on Bronchoscopic Intubation Techniques |
| Date of disclosure of the study information | 2026/06/26 |
| Last modified on | 2026/06/25 14:42:43 |
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Basic information
Public title
A Study on the Effects of Intubation Training on Bronchoscopic Intubation Techniques
Acronym
Not applicable
Scientific Title
A Study on the Effects of Intubation Training on Bronchoscopic Intubation Techniques
Scientific Title:Acronym
Not applicable
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates whether the use of models made from LEGO bricks (hereinafter referred to as LEGO bricks) in conjunction with lectures on the principles and management of difficult airways can improve bronchoscopic intubation skills.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the change in the success rate of fiberoptic bronchoscope-guided tracheal intubation using a difficult-airway mannequin constructed from LEGO blocks before and after theoretical instruction on difficult-airway management using the LEGO-block model. The success rates before and after the instruction will be compared using McNemar's test.
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
Participants will first perform fiberoptic bronchoscope-guided tracheal intubation using a difficult-airway mannequin constructed from LEGO blocks. They will then receive theoretical instruction on difficult-airway management using the LEGO-block model. After the instruction, they will perform fiberoptic bronchoscope-guided tracheal intubation again using the same model.
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
Participants must meet all of the following criteria:
Affiliated with Tohoku University and involved in difficult-airway management as one of the following: an anesthesiology resident, an emergency medicine resident, or a nurse working in the operating room, intensive care unit, or emergency department.
Provides written informed consent to participate in the study.
Key exclusion criteria
Those involved in the preliminary survey to determine the required sample size
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
81-22-717-7321
masanori.yamauchi.b1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Takahashi |
Organization
Graduate School of Medicine, Tohoku University
Division name
Department of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
81-22-717-7321
Homepage URL
kazuhiro.takahashi.c4@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Non
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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 | 06 | Month | 26 | 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 | 05 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 05 | 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 | 06 | Month | 25 | Day |
Last modified on
| 2026 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070579
