UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052455 |
|---|---|
| Receipt number | R000059810 |
| Scientific Title | correlation between mandibular condyle movement and difficult airway |
| Date of disclosure of the study information | 2023/10/16 |
| Last modified on | 2023/10/10 12:57:50 |
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Basic information
Public title
correlation between forward condyle movement and difficult airway
Acronym
correlation between mandibular condyle movement and difficult airway
Scientific Title
correlation between mandibular condyle movement and difficult airway
Scientific Title:Acronym
correlation between mandibular condyle movement and difficult airway
Region
| Japan |
Condition
Condition
we enroll patients who undergo elective surgeries with endotracheal intubation under general anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the purpose of this research is to observe the correlation between forward mandibular condyle movement and other valuable predictive indicators of difficult laryngoscopy in classifying laryngoscopy and predicting difficult laryngoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate the ultrasonographic assessment of distance of forward movement of mandibular condyle during upper lip bite test and observe the influence on intubation difficulty.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We enrolled patients who undergo elective surgeries with endotracheal intubation under general anesthesia and are of ASA physical status 1-3 and 18-90 years of age.
Key exclusion criteria
We exclude patients with no teeth, with maxillofacial injuries, inability to cooperate.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata prefectural tokamachi hospital
Division name
department of anesthesiology
Zip code
9480065
Address
3 chome minami,32-9, takada, tokamachi city, niigata prefecture
TEL
0257575566
seijihida@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Hida |
Organization
Niigata prefectural tokamachi Hospital
Division name
department of anesthesiology
Zip code
950-2113
Address
3 chome minami,32-9, takada, tokamachi city, niigata prefecture
TEL
0257575566
Homepage URL
seijihida@yahoo.co.jp
Sponsor or person
Institute
Niigata prefectural tokamachi hospital
Institute
Department
Personal name
Funding Source
Organization
Niigata prefectural tokamachi hospital
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
niigata prefectural tokamachi hospital
Address
3 chome minami,32-9, takada, tokamachi city, niigata prefecture
Tel
0257575566
seijihida@yahoo.co.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
| 2023 | Year | 10 | 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
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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this research is to observe the correlation between temporomandibular joint mobility during upper bite test and other valuable predictive indicators of difficult laryngoscopy, and to calculate the predictive value of temporomandibular joint mobility. We evaluated the maximum movement of temporomandibular joint during upper bite test with ultrasound.
Management information
Registered date
| 2023 | Year | 10 | Month | 10 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059810
| Research Plan | |
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| 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 |
