UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060682 |
|---|---|
| Receipt number | R000068890 |
| Scientific Title | Risk factors associated with epiglottal displacement during tracheal intubation: A multicenter retrospective exploratory analysis |
| Date of disclosure of the study information | 2026/02/16 |
| Last modified on | 2026/02/16 15:19:17 |
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Basic information
Public title
Risk factors associated with epiglottal displacement during tracheal intubation: A multicenter retrospective exploratory analysis
Acronym
Epiglottal Displacement during Intubation Study
Scientific Title
Risk factors associated with epiglottal displacement during tracheal intubation: A multicenter retrospective exploratory analysis
Scientific Title:Acronym
Epiglottal Displacement during Intubation Study
Region
| Japan |
Condition
Condition
Patients who participated in the following study and provided consent for the secondary use of their samples and data:
Study title:Examining the intubation complications of different glottal elevation techniques using the McGRATH MAC videolaryngoscope.: A multicentre randomized controlled trial
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tracheal intubation is an essential procedure in general anesthesia; however, epiglottal displacement may increase the risk of airway edema, leading to a worsened glottic view during reintubation, difficult intubation, and potential airway injury. Despite these concerns, no studies to date have systematically investigated the incidence of epiglottic downfolding in clinical practice or the patient- and operator-related factors associated with its occurrence. This study aims to identify risk factors associated with the presence or absence of epiglottal displacement during tracheal intubation under general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk factors for epiglottal displacement during tracheal intubation
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who participated in the following study and provided consent for secondary use of samples and information
Study Title:Examining the intubation complications of different glottal elevation techniques using the McGRATH MAC videolaryngoscope.: A multicentre randomized controlled trial
Key exclusion criteria
Not applicable for observational studies
Target sample size
1034
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Hirai |
Organization
Wakayama Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama
TEL
+81-73-441-0611
akihri@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Hirai |
Organization
Wakayama Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
641-8509
Address
811-1 Kimiidera, Wakayama City, Wakayama
TEL
+81-73-441-0611
Homepage URL
akihri@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University School of Medicine
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
Wakayama Medical University Ethics Review Committee
Address
811-1 Kimiidera, Wakayama City, Wakayama
Tel
0734410897
wa-rinri@wakayama-med.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 | 02 | Month | 16 | 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
1034
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter retrospective observational study
Management information
Registered date
| 2026 | Year | 02 | Month | 16 | Day |
Last modified on
| 2026 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068890
