UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034041 |
|---|---|
| Receipt number | R000038805 |
| Scientific Title | Study on appropriate size choice of supraglottic device, i-jel |
| Date of disclosure of the study information | 2018/11/07 |
| Last modified on | 2018/11/06 16:32:54 |
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Basic information
Public title
Study on appropriate size choice of supraglottic device, i-jel
Acronym
Appropriate size choice of i-jel
Scientific Title
Study on appropriate size choice of supraglottic device, i-jel
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shinji Kawahito |
Organization
Shikoku Central Hospital
Division name
Anesthesiology
Zip code
Address
2233, Kawanoe, Shikokuchuo, Ehime
TEL
0896583515
kawahito.shinji@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Kawahito |
Organization
Shikoku Central Hospital
Division name
Anesthesiology
Zip code
Address
2233, Kawanoe, Shikokuchuo, Ehime
TEL
0896583515
Homepage URL
kawahito.shinji@tokushima-u.ac.jp
Sponsor or person
Institute
Shikoku Central Hospital
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038805
