UMIN-CTR Clinical Trial

Basic information
Public title	Comparison with LMA Proseal, LMA Supreme and i-gel
Acronym	Comparison with LMA Proseal, LMA Supreme and i-gel, at general anesthetic induction, maintenance, insertion of tracheal tube.
Scientific Title	Comparison with LMA Proseal, LMA Supreme and i-gel
Scientific Title:Acronym	Comparison with LMA Proseal, LMA Supreme and i-gel, at general anesthetic induction, maintenance, insertion of tracheal tube.
Region	Japan

Condition
Condition	Patients undergoing general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim is finding the characteristic of each device, especially paying attention to easiness of Insertion, time-dependent change and tracheal intubation through each device.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	easiness of Insertion: a ratio of success time-dependent change: the position related to larynx tracheal intubation: a ratio of success
Key secondary outcomes	The time depending on the insertion, the number of times, seal pressure, easiness of the insertion of a stomach tube, vital, performer's evaluation.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	LMA ProSeal group
Interventions/Control_2	LMA Supreme group
Interventions/Control_3	i-gel group
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	Adults undergoing general anesthesia
Key exclusion criteria	Emergency operation, pregnant, full stomach, a respiration disorder, facial disorder, laparoscopic operation, lateral and prone position.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shuzo Oshita
Organization	Tokushima university hospital
Division name	Anesthesia
Zip code
Address	2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Michiko Kinoshita
Organization	Tokushima university hospital
Division name	Anesthesia
Zip code
Address	2-50-1, Kuramoto-cho, Tokushima-shi, Tokushima
TEL
Homepage URL
Email

Sponsor
Institute	Tokushima university hospital anesthesia
Institute
Department

Funding Source
Organization	none
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
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	徳島大学病院

Other administrative information
Date of disclosure of the study information	2009 Year 11 Month 20 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	Terminated
Date of protocol fixation	2010 Year 01 Month 01 Day
Date of IRB	2010 Year 01 Month 01 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 11 Month 16 Day
Last modified on	2020 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000003344