UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of proper tracheal tube fixation and calculation method in Japanese
Title of the study (Brief title)	Calculation of appropriate position of tracheal tube
Region	Japan

Condition
Condition	Elective patient of endovascular neurosurgery
Classification by specialty	Anesthesiology Neurosurgery Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarify the fixation and the calculation process of the best tracheal tube in the contemporary Japanese.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Distance from angle of mouth to bifurcation of trachea
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	Adult patient who enforces elective operation by department of endovascular neurosurgery under general anaesthesia with radioscopy device
Key exclusion criteria	Patient who obviously has abnormality of jaw and face,patient with difficult communication and emergency operation
Target sample size	160

Research contact person
Name of lead principal investigator	Koji Takano
Organization	The Jikei university hospital
Division name	Department of anesthesiology
Address	3-25-8 Nishishihinbashi Minato-ku Tokyo-to
TEL	03-3433-1111
Email	highfield.lightmaster@gmail.com

Public contact
Name of contact person	Koji Takano
Organization	The Jikei university hospital
Division name	Department of anesthesiology
Address	3-25-8 Nishishihinbashi Minato-ku Tokyo-to
TEL	03-3433-1111
Homepage URL
Email	highfield.lightmaster@gmail.com

Sponsor
Institute	The Jikei university of medicine Department of anesthesiology
Institute
Department

Funding Source
Organization	The Jikei university of medicine Department of anesthesiology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	東京慈恵会医科大学附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 15 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design: case series study Recruitment policy of object: All patients who are scheduled elective operation in treatment part in cerebral blood vessel in this hospital between August, 2015 and March, 2016, and agree with registration criteria. Registration criteria: the research objects are elective patients who undergo the operation by the endovascular neurosurgery with radioscopy device under the general anaesthesia at Jikei University Hospital. Exclusion criteria:Patient who obviously has jaw and facial malformation, patient of emergency operation, and patient with difficult communication. Measured parameter: Age, sexuality, height, weight, complication, internal diameter of endotracheal tube, depth of endotracheal tube measured by angle of mouth, and distance between endotracheal tube tip and bifurcation of trachea.

Management information
Registered date	2015 Year 11 Month 18 Day
Last modified on	2017 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022894