UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on appropriate size choice of supraglottic device, i-jel
Title of the study (Brief title)	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	Shinji Kawahito
Organization	Shikoku Central Hospital
Division name	Anesthesiology
Address	2233, Kawanoe, Shikokuchuo, Ehime
TEL	0896583515
Email	kawahito.shinji@tokushima-u.ac.jp

Public contact
Name of contact person	Shinji Kawahito
Organization	Shikoku Central Hospital
Division name	Anesthesiology
Address	2233, Kawanoe, Shikokuchuo, Ehime
TEL	0896583515
Homepage URL
Email	kawahito.shinji@tokushima-u.ac.jp

Sponsor
Institute	Shikoku Central Hospital
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038805