UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043615 |
|---|---|
| Receipt number | R000049427 |
| Scientific Title | Comparison of oropharyngeal leak pressure between i-gel and LMA-Supreme in awake craniotomy: a randomized controlled trial |
| Date of disclosure of the study information | 2021/03/18 |
| Last modified on | 2025/08/21 11:25:09 |
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Basic information
Public title
Comparison of oropharyngeal leak pressure between i-gel and LMA-Supreme in awake craniotomy: a randomized controlled trial
Acronym
Comparison of efficacy of supraglottic airway device in awake craniotomy
Scientific Title
Comparison of oropharyngeal leak pressure between i-gel and LMA-Supreme in awake craniotomy: a randomized controlled trial
Scientific Title:Acronym
Comparison of efficacy of supraglottic airway device in awake craniotomy
Region
| Japan |
Condition
Condition
brain tumor and seizure
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy of i-gel and LMA-Supreme in awake craniotomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Oropharyngeal leak pressure after the positioning for awake craniotomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The airway management using i-gel during awake craniotomy
Interventions/Control_2
The airway management using LMA-Supreme during awake craniotomy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo brain tumor resection or seizure focus resection under awake craniotomy
Key exclusion criteria
Patients who are not suitable for airway management using suplaglottic airway device
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Chaki |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
291, South 1, West 16, Chuo-ku, Sapporo
TEL
011-611-2111
chakitomohiro0728@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Chaki |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
0608543
Address
291, South 1, West 16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
https://web.sapmed.ac.jp/masui/
chakitomohiro0728@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
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
Sapporo Medical University School of Medicine
Address
291, South 1, West 16, Chuo-ku, Sapporo
Tel
09070518560
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）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 15 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049427
