UMIN-CTR Clinical Trial

Basic information
Public title	Investigation for insertion of i-gel
Acronym	Investigation for insertion of i-gel
Scientific Title	Investigation for insertion of i-gel
Scientific Title:Acronym	Investigation for insertion of i-gel
Region	Japan

Condition
Condition	Cases, inserted the i-gel
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	efficacy
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of insertion success
Key secondary outcomes	Number of insertion success

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Cases, inserted the i -gel
Key exclusion criteria	Cases, not inserted the i-gel
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hironobu Middle name Last name Ueshima
Organization	Showa university hospital
Division name	Anesthesiology
Zip code	142-8666
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8575
Email	ueshimhi@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Hironobu Middle name Last name Ueshima
Organization	Showa university hospital
Division name	Anesthesiology
Zip code	142-8666
Address	1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8575
Homepage URL
Email	ueshimhi@med.showa-u.ac.jp

Sponsor
Institute	Showa university hospital
Institute
Department

Funding Source
Organization	Showa university hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Showa university hospital
Address	1-5-8, hatanodai, shinagawa-ku, tokyo
Tel	03-3784-8575
Email	03-3784-8575

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 01 Month 31 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	500
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	Completed
Date of protocol fixation	2017 Year 01 Month 31 Day
Date of IRB	2017 Year 01 Month 31 Day
Anticipated trial start date	2017 Year 01 Month 31 Day
Last follow-up date	2021 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	general anesthesia between April and September, 2017 the cases, inserted the i-gel the success rate of the i-gel insertion the success number of the i-gel insertion

Management information
Registered date	2018 Year 01 Month 31 Day
Last modified on	2019 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035485