UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031531 |
|---|---|
| Receipt number | R000028847 |
| Scientific Title | The clinical evaluation of insertion depth of pediatric i-gel based on fiberoptic view and leak pressure: should the i-gel be deeply inserted or not |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/03/01 15:34:33 |
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Basic information
Public title
The clinical evaluation of insertion depth of pediatric i-gel based on fiberoptic view and leak pressure: should the i-gel be deeply inserted or not
Acronym
The clinical evaluation of insertion depth of pediatric i-gel
Scientific Title
The clinical evaluation of insertion depth of pediatric i-gel based on fiberoptic view and leak pressure: should the i-gel be deeply inserted or not
Scientific Title:Acronym
The clinical evaluation of insertion depth of pediatric i-gel
Region
| Japan |
Condition
Condition
pediatric surgery
plastic surgery
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study was to investigate whether i-gel should be inserted until resistance is felt or let it slide out, including leak pressure and fiberoptic view.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
leak pressure
Key secondary outcomes
insertion depth
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
| 1 | years-old | <= |
Age-upper limit
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children who received general anesthesia
10kg<Body weight<25kg
Key exclusion criteria
Children who have airway problem
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Yoshino |
Organization
St. Mary's Hospital
Division name
Department of Anesthesia
Zip code
Address
422 Tsubukuhonmachi, Kurume, Fukuoka
TEL
0942-35-3322
j-yoshino@st-mary-med.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosie Naito |
Organization
St. Mary's Hospital
Division name
institute of clinical, education and research
Zip code
Address
422 Tsubukuhonmachi, Kurume, Fukuoka
TEL
0942-35-3322
Homepage URL
naito-yoshie@st-mary-med.or.jp
Sponsor or person
Institute
St. Mary's Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Mary's Hospital
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
| 2018 | Year | 03 | Month | 01 | 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 | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
| 2018 | Year | 02 | Month | 09 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
The aim of the current study was to evaluate which i-jel position is better for the secure fixation in pediatric patients, including where the operator feels some resistance during the insertion (position A) or the device is allowed to emerge from the oral cavity after the position A (position B). Accordingly, we investigated the appropriate insertion depth, leak pressure, and fiberoptic view of the epiglottis in the two positions when using the i-gel (size #2) in pediatric surgical patients.
Management information
Registered date
| 2018 | Year | 03 | Month | 01 | Day |
Last modified on
| 2018 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028847
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
