UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029547 |
|---|---|
| Receipt number | R000033753 |
| Scientific Title | The examination of the insertion length of i-gel for pediatric patients |
| Date of disclosure of the study information | 2017/10/16 |
| Last modified on | 2019/10/23 08:25:38 |
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Basic information
Public title
The examination of the insertion length of i-gel for pediatric patients
Acronym
The examination of the insertion length of i-gel for pediatric patients
Scientific Title
The examination of the insertion length of i-gel for pediatric patients
Scientific Title:Acronym
The examination of the insertion length of i-gel for pediatric patients
Region
| Japan |
Condition
Condition
The pediatric patients under general anesthesia for surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is the investigation to the appropiate insertion length of i-gel for children
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The appropiate insertion length of i-gel
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The trial of airway management by i-gel which insert the predictive insertion length
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
children weighing 10-25kg that are the appropriate weight of i-gel size 2
Key exclusion criteria
children with previous or anticipated airway problems
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | asaka |
| Middle name | |
| Last name | watanabe |
Organization
Shizuoka children's hospital
Division name
Anesthesiology
Zip code
4200086
Address
860 Urushiyama,Aoi-ku,Shizuoka,Japan
TEL
0542476251
awminy27@yahoo.co.jp
Public contact
Name of contact person
| 1st name | asaka |
| Middle name | |
| Last name | watanabe |
Organization
Shizuoka children's hospital
Division name
Anesthesiology
Zip code
4208660
Address
860 Urushiyama,Aoi-ku,Shizuoka,Japan
TEL
0542476251
Homepage URL
awminy27@yahoo.co.jp
Sponsor or person
Institute
Shizuoka children's hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka children's hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka children's hospital
Address
860 Urushiyama,Aoi-ku,Shizuoka,Japan
Tel
0542476251
awminy27@yahoo.co.jp
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
静岡県立こども病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 16 | 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
54
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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 04 | 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
| 2017 | Year | 10 | Month | 13 | Day |
Last modified on
| 2019 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033753
