UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030706 |
|---|---|
| Receipt number | R000035058 |
| Scientific Title | Comparison of tolerance for head rotation, i-gelTM vs SupremeTM on assumption in awake craniotomy |
| Date of disclosure of the study information | 2018/01/05 |
| Last modified on | 2021/03/15 10:34:25 |
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Basic information
Public title
Comparison of tolerance for head rotation, i-gelTM vs SupremeTM on assumption in awake craniotomy
Acronym
The tolerance of i-gelTM vs SupremeTM on head rotation
Scientific Title
Comparison of tolerance for head rotation, i-gelTM vs SupremeTM on assumption in awake craniotomy
Scientific Title:Acronym
The tolerance of i-gelTM vs SupremeTM on head rotation
Region
| Japan |
Condition
Condition
General anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the superiority of i-gel or Supreme for head rotation. The results of this study will suggest the better device for airway management for awake craniotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oropharyngeal Leak Pressure: OPLP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Airway management using i-gel.
The duration of intervention is only during general anesthesia.
Interventions/Control_2
Airway management using Supreme.
The duration of intervention is only during general anesthesia.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients received general anesthesia
ASA-PS 1-3
Key exclusion criteria
Patients who have the risk of barotrauma and aspiration, and restriction for head rotation.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Tokinaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
chakitomohiro0728@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Tokinaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
South 1, West 16, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
chakitomohiro0728@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Anesthesiology, Takikawa City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Sapporo Medical School of University Hospital
Address
291, South 1, West 16, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
chakitomohiro0728@yahoo.co.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
札幌医科大学附属病院（北海道）、滝川市立病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 05 | 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
| 2017 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 05 | Day |
Last modified on
| 2021 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035058
