UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047320 |
|---|---|
| Receipt number | R000053677 |
| Scientific Title | Examination of maxillofacial risk factors affecting the amount of mouth opening under general anesthesia |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2022/04/11 16:20:36 |
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Basic information
Public title
Examination of maxillofacial risk factors affecting the amount of mouth opening under general anesthesia
Acronym
Examination of maxillofacial risk factors affecting the amount of mouth opening under general anesthesia
Scientific Title
Examination of maxillofacial risk factors affecting the amount of mouth opening under general anesthesia
Scientific Title:Acronym
Examination of maxillofacial risk factors affecting the amount of mouth opening under general anesthesia
Region
| Japan |
Condition
Condition
Surgical patients requiring tracheal intubation under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the frequency of mouth opening restriction under general anesthesia
Basic objectives2
Others
Basic objectives -Others
Elucidate the mechanisms of mouth opening restriction that cannot be predicted by existing pre-operative airway assessment.
Investigate cervical spine positions that may improve mouth opening .
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mouth opening
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Surgical patients requiring tracheal intubation under general anesthesia
ASA PS1-2
Key exclusion criteria
(1)Patients with dentures
(2)Patients with fluctuating teeth
(3)Patients with cognitive impairment
(4)Patients with restricted neck retroflexion
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | AYA |
| Middle name | |
| Last name | YAMAMURA |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City
TEL
0459497000
ayayamamura128@gmail.com
Public contact
Name of contact person
| 1st name | AYA |
| Middle name | |
| Last name | YAMAMURA |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City
TEL
0459497000
Homepage URL
ayayamamura128@gmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education,Culuture,Sports,Science and Technology (MEXT)
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Research Involving Human Subjects at Showa University
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-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
| 2022 | Year | 04 | 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
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
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measure and compare mouth openings before and after induction of general anesthesia
Evaluate the factors that contribute most to mouth opening restriction among the preoperative airway assessment items
Compare the difference in mouth opening amounts by cervical position after induction of general anesthesia
Management information
Registered date
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2022 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053677
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
