UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017971 |
|---|---|
| Receipt number | R000020824 |
| Scientific Title | Retrospective study about difficult airway management of awake craniotomy |
| Date of disclosure of the study information | 2015/06/19 |
| Last modified on | 2015/06/18 23:08:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Retrospective study about difficult airway management of awake craniotomy
Acronym
Investigation for risk factor of difficult airway during awake craniotomy
Scientific Title
Retrospective study about difficult airway management of awake craniotomy
Scientific Title:Acronym
Investigation for risk factor of difficult airway during awake craniotomy
Region
| Japan |
Condition
Condition
Brain tumor, epilepsy
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to promote safe anesthetic management of awake craniotomy by investigating for risk factor of difficult airway during surgical procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Interruption of assessing verbal or motor function during surgery
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
| 5 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who are undergo awake craniotomy in Sapporo Medical University Hospital
Key exclusion criteria
Patients who refuse to consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomo Hayase |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
West 16, South 1, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
+81116112111
eric.core2006@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomo Hayase |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
West 16, South 1, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
+81116112111
Homepage URL
eric.core2006@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | 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
Primary end-point was set as occurrence of interruption of tasking for verbal or motor function during surgery.
Secondary end-points were set as taking times for tracheal intubation during surgery, emergence from general anesthesia, and total amount of consumptions of anesthetic agents during surgery.
Management information
Registered date
| 2015 | Year | 06 | Month | 18 | Day |
Last modified on
| 2015 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020824
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
