UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034041
Receipt number R000038805
Scientific Title Study on appropriate size choice of supraglottic device, i-jel
Date of disclosure of the study information 2018/11/07
Last modified on 2018/11/06 16:32:54

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Study on appropriate size choice of supraglottic device, i-jel

Acronym

Appropriate size choice of i-jel

Scientific Title

Study on appropriate size choice of supraglottic device, i-jel

Scientific Title:Acronym

Appropriate size choice of i-jel

Region

Japan


Condition

Condition

The adult patients who undergo general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We maximize leak pressure by choosing appropriate size of supraglottic appliance i-gel and observe good airway maintenance for epiglottis, glottis findings.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reak pressure, airway pressure

Key secondary outcomes

Trachea fiber findings, presence or absence of change to endotracheal intubation, the appliance which we used at endotracheal intubation, complications with the endotracheal intubation


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

20 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

The adults who require airway maintenance by a supraglottic device for general anesthesia

Key exclusion criteria

The patients who have been already performed endotracheal intubation, the patients with the disease in the respiratory tract, the patients who judged that a study person in charge was inadequate.

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinji Kawahito

Organization

Shikoku Central Hospital

Division name

Anesthesiology

Zip code


Address

2233, Kawanoe, Shikokuchuo, Ehime

TEL

0896583515

Email

kawahito.shinji@tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinji Kawahito

Organization

Shikoku Central Hospital

Division name

Anesthesiology

Zip code


Address

2233, Kawanoe, Shikokuchuo, Ehime

TEL

0896583515

Homepage URL


Email

kawahito.shinji@tokushima-u.ac.jp


Sponsor or person

Institute

Shikoku Central Hospital

Institute

Department

Personal name



Funding Source

Organization

Shikoku Central Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

IMS Fujimi General Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2018 Year 11 Month 07 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

2018 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Open public recuiting


Management information

Registered date

2018 Year 09 Month 05 Day

Last modified on

2018 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038805


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name