UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053465 |
|---|---|
| Receipt number | R000061019 |
| Scientific Title | Comparison of Videolaryngoscope versus Macintosh Laryngoscope in using airway management simulator by tracheal intubation Novice |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2025/07/31 15:01:34 |
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Basic information
Public title
Comparison of Videolaryngoscope versus Macintosh Laryngoscope in using airway management simulator by tracheal intubation Novice
Acronym
Comparison of Videolaryngoscope versus Macintosh Laryngoscope in using airway management simulator by tracheal intubation Novice
Scientific Title
Comparison of Videolaryngoscope versus Macintosh Laryngoscope in using airway management simulator by tracheal intubation Novice
Scientific Title:Acronym
Comparison of Videolaryngoscope versus Macintosh Laryngoscope in using airway management simulator by tracheal intubation Novice
Region
| Japan |
Condition
Condition
simulator
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparison of the utility of the video laryngoscope and the Macintosh laryngoscope in endotracheal intubation maneuvers using a simulator for airway management training by individuals
with no prior experience in endotracheal intubation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intubation time difference between laryngoscope groups
Key secondary outcomes
Maxillary incisor contact pressure difference between laryngoscope groups
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Dental students with no prior experience in endotracheal intubation on patients or manikin models.
Key exclusion criteria
Adults with experience in endotracheal intubation on patients or manikin models.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | KAWAHITO |
Organization
Tokushima University Hospital
Division name
Department of Dental Anesthesiology
Zip code
770-8504
Address
2-50-2, Kuramoto, Tokushima, Japan
TEL
+81-88-633-7367
kawahito.shinji@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | EGUCHI |
Organization
Tokushima university Hospital
Division name
Department of Dental Anesthesiology
Zip code
770-8504
Address
2-50-1, kuramoto ,tokushima,Japan
TEL
+81-88-633-7367
Homepage URL
seguchi@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima Univesity
Institute
Department
Personal name
Funding Source
Organization
Japan Medicalnext Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushima Univesity Hospital
Address
2-50-1, Kuramoto-cho, Tokushima, JAPAN
Tel
+81-88-633-7958
brinshoshienk@tokushima-u.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
| 2024 | Year | 02 | 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
| Delay expected |
Results Delay Reason
The reason for the delay in reporting the research results is due to an extension of the deadline (until March 31, 2025).
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
| 2022 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061019
