UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062681 |
|---|---|
| Receipt number | R000071731 |
| Scientific Title | Association between preoperative three-dimensional jaw motion analysis and passive mouth opening after induction of anesthesia in patients scheduled for general anesthesia: a prospective observational study |
| Date of disclosure of the study information | 2026/08/25 |
| Last modified on | 2026/08/24 12:27:15 |
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Basic information
Public title
A study of the relationship between preoperative mouth-opening movements and mouth opening after induction of general anesthesia
Acronym
3D Jaw Motion Study
Scientific Title
Association between preoperative three-dimensional jaw motion analysis and passive mouth opening after induction of anesthesia in patients scheduled for general anesthesia: a prospective observational study
Scientific Title:Acronym
3D Jaw Motion Study
Region
| Japan |
Condition
Condition
Adult surgical patients scheduled for tracheal intubation under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the association between preoperative mouth-opening motion variables obtained by three-dimensional jaw motion analysis and passive mouth opening after induction of general anesthesia.
Basic objectives2
Others
Basic objectives -Others
Exploration of dynamic jaw-motion variables for preoperative airway assessment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association between preoperative 3D jaw-motion variables measured at the preanesthetic assessment and passive mouth opening (interincisor distance, mm) in the supine neutral position measured on the day of surgery after induction of general anesthesia at a BIS value < 60 and a TOF count of 0.
Key secondary outcomes
Passive mouth opening in the supine neck-extended position after induction of general anesthesia on the day of surgery; differences in mouth opening between the neutral and neck-extended positions and from preoperative maximum mouth opening; the frequency of passive mouth opening <= 30 mm; differences in preoperative 3D jaw-motion variables between the head-contact and head-free conditions; and the feasibility and safety of the study measurements.
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
1. Patients aged 18 years or older who are scheduled for tracheal intubation under general anesthesia at Showa Medical University Northern Yokohama Hospital.
2. Patients who provide written informed consent to participate in the study.
Key exclusion criteria
Patients with apparent limitation of mouth opening, pain on mouth opening, or severe temporomandibular joint symptoms; patients for whom neck extension is inappropriate; patients scheduled for nonstandard airway management or with a strongly anticipated difficult airway for whom the study measurements are inappropriate; patients undergoing emergency surgery or at high risk of aspiration; patients for whom mouth-opening measurement or marker placement is difficult because of dental or skin conditions; pregnant patients or patients who may be pregnant; patients unable to provide informed consent or understand the study procedures; and patients considered unsuitable by the principal investigator or attending anesthesiologist.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Yamamura |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
045-949-7000
ayamamura@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yamamura |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1 Chigasaki-chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL
045-949-7000
Homepage URL
ayamamura@med.showa-u.ac.jp
Sponsor or person
Institute
Showa Medical University
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
Showa Medical University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555, Japan
Tel
03-3784-8129
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
| 2026 | Year | 08 | Month | 25 | 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
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center prospective observational study. The study period is from institutional authorization through March 31, 2029. Eligible adult patients scheduled for tracheal intubation under general anesthesia at Showa Medical University Northern Yokohama Hospital will be invited to participate. Preoperative 3D jaw-motion variables and passive mouth opening after induction of general anesthesia will be measured. The target sample size is 30.
Management information
Registered date
| 2026 | Year | 08 | Month | 25 | Day |
Last modified on
| 2026 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071731
