UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013024 |
|---|---|
| Receipt number | R000015203 |
| Scientific Title | The time-dependent change of leak pressure of i-gel in children |
| Date of disclosure of the study information | 2014/01/31 |
| Last modified on | 2018/01/21 10:41:53 |
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Basic information
Public title
The time-dependent change of leak pressure of i-gel in children
Acronym
The time-dependent change of leak pressure of i-gel in children
Scientific Title
The time-dependent change of leak pressure of i-gel in children
Scientific Title:Acronym
The time-dependent change of leak pressure of i-gel in children
Region
| Japan |
Condition
Condition
pediatric patients considered suitable for general anesthesia with i-gel
Classification by specialty
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the time-dependant change of i-gel in children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
leak pressure
Key secondary outcomes
bronchoscopic view of the larynx, ease of insertion, number of insertion attempts, complications occurring during insertion
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
| 3 | months-old | <= |
Age-upper limit
| 72 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA-PS 1 or 2, <3 hrs of proposed operation, supine position, patients for whom anesthetic management using gel size 1.5 or 2 is planed
Key exclusion criteria
emergent surgery, patients with high risk of aspiration, patients with difficult airway, patients with congenital deformation of airway, patients with cervical spine disease, patients with symptom of airway infection, patients with sever respiratory/cardiovascular disease
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirata Naoyuki |
Organization
Sapporo Medical University
Division name
Department of Anesthesiology
Zip code
Address
south 1 west 16 chuo-ku sapporo
TEL
011-611-2111
naohirata@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshikawa Yusuke |
Organization
Sapporo Medical University
Division name
Department of Anesthesiology
Zip code
Address
south 1 west 16 chuo-ku sapporo
TEL
011-611-2111
Homepage URL
yusuke_19_@hotmail.com
Sponsor or person
Institute
Department of Anesthesiology, Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Anesthesiology, Hokkaido Medical Center for Child Health and Rehabilitation
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
札幌医科大学附属病院（北海道）、北海道立子ども総合医療・療育センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 31 | 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
| 2014 | Year | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcome and secondary outcomes are assessed during general anesthesia with i-gel
Management information
Registered date
| 2014 | Year | 01 | Month | 30 | Day |
Last modified on
| 2018 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015203
