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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002767
Receipt No. R000003344
Scientific Title Comparison with LMA Proseal, LMA Supreme and i-gel
Date of disclosure of the study information 2009/11/20
Last modified on 2009/11/16

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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 Preinitiation
Date of protocol fixation
2010 Year 01 Month 01 Day
Date of IRB
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
2009 Year 11 Month 16 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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