UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019842 |
|---|---|
| Receipt number | R000022894 |
| Scientific Title | Evaluation of proper tracheal tube fixation and calculation method in Japanese |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2017/05/21 01:29:15 |
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Basic information
Public title
Evaluation of proper tracheal tube fixation and calculation method in Japanese
Acronym
Calculation of appropriate position of tracheal tube
Scientific Title
Evaluation of proper tracheal tube fixation and calculation method in Japanese
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Koji Takano |
Organization
The Jikei university hospital
Division name
Department of anesthesiology
Zip code
Address
3-25-8 Nishishihinbashi Minato-ku Tokyo-to
TEL
03-3433-1111
highfield.lightmaster@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Takano |
Organization
The Jikei university hospital
Division name
Department of anesthesiology
Zip code
Address
3-25-8 Nishishihinbashi Minato-ku Tokyo-to
TEL
03-3433-1111
Homepage URL
highfield.lightmaster@gmail.com
Sponsor or person
Institute
The Jikei university of medicine
Department of anesthesiology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022894
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
