UMIN-CTR Clinical Trial

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
Email	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
Email	ayayamamura128@gmail.com

Sponsor
Institute	Showa University Northern Yokohama Hospital Department of Anesthesiology
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053677