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 2021/03/15 10:32:36

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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 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

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

Value
https://center6.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