UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018281 |
|---|---|
| Receipt number | R000021162 |
| Scientific Title | Pediatric I-gel insertion and anatomical consideration |
| Date of disclosure of the study information | 2015/07/13 |
| Last modified on | 2016/01/13 01:49:40 |
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Basic information
Public title
Pediatric I-gel insertion and anatomical consideration
Acronym
I-gel for pediatric patients
Scientific Title
Pediatric I-gel insertion and anatomical consideration
Scientific Title:Acronym
I-gel for pediatric patients
Region
| Japan |
Condition
Condition
Using I-gel for airway management in pediatric patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is no horizontal line which stands ideal position of teeth for pediatric sizes because of the greater variability in the length of the oro-phatyngeal-laryngeal arch in children. We investigated that the depth of i-gel were measured in each pediatric sizes from size 1.5 to 2.5.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
One was the distance between the teeth and the connector wing. Two was the insertion length.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Insertion of the i-gel
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
| 0 | years-old | <= |
Age-upper limit
| 13 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The case of using I-gel for airway management in pediatric patients.
Key exclusion criteria
The pediatric patient dose not fit the I-gel.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Ozaki |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesia
Zip code
Address
8-1 Kawadachou Shinjyukuku
TEL
03-3353-8111
mozaki@anes.twmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukako Abukawa |
Organization
Tokyo Women's Medical University
Division name
Department of Anesthesia
Zip code
Address
8-1 Kawadachou Shinjyukuku
TEL
03-3353-8111
Homepage URL
yukako1@rg8.so-net.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
There is a correlation between the insertion lenght and hight.
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
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
Management information
Registered date
| 2015 | Year | 07 | Month | 13 | Day |
Last modified on
| 2016 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021162
