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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043615
Receipt No. 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 2021/03/15

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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
Email 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/
Email chakitomohiro0728@yahoo.co.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

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
Email 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
2021 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049427

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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