UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020495 |
|---|---|
| Receipt number | R000023664 |
| Scientific Title | Learning curve for i-gelTM insertion: a prospective observational study |
| Date of disclosure of the study information | 2016/01/08 |
| Last modified on | 2018/05/19 12:29:18 |
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Basic information
Public title
Learning curve for i-gelTM insertion: a prospective observational study
Acronym
Learning curve for i-gelTM insertion
Scientific Title
Learning curve for i-gelTM insertion: a prospective observational study
Scientific Title:Acronym
Learning curve for i-gelTM insertion
Region
| Japan |
Condition
Condition
Patients undergo general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the learning curve for i-gelTM insertion
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The learning curve for the successful i-gelTM insertion
Key secondary outcomes
Time for i-gelTM insertion
The rate of blood adherence to i-gelTM
The success rate of bag-and mask ventilation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Junior residents
Key exclusion criteria
Junior residents who have an experience of insertion i-gelTM
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakanishi |
Organization
JCHO Tokuyama Central Hospital
Division name
Anesthesiology
Zip code
Address
1-1 Kohdacho, Shunan city
TEL
0834-28-4411
nakanishi.anest@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakanishi |
Organization
JCHO Tokuyama Central Hospital
Division name
Anesthesiology
Zip code
Address
1-1 Kohdacho, Shunan city
TEL
0834-28-4411
Homepage URL
nakanishi.anest@gmail.com
Sponsor or person
Institute
JCHO Tokuyama Central Hospital, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
JCHO Tokuyama Central Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 08 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: A prospective non-interventional observational study
Recruitment: Junior residents under training our hospital
(From January 2016 to March 2018)
Management information
Registered date
| 2016 | Year | 01 | Month | 08 | Day |
Last modified on
| 2018 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023664
