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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030706
Receipt No. 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 2019/08/01

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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
Email 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
Email chakitomohiro0728@yahoo.co.jp

Sponsor
Institute Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department

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
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)、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 Open public recruiting
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
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 05 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035058

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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