UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002767 |
|---|---|
| Receipt number | 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 | 2020/11/26 10:11:45 |
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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
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
Sponsor or person
Institute
Tokushima university hospital anesthesia
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003344
