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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018281
Receipt No. 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

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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
Email 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
Email yukako1@rg8.so-net.ne.jp

Sponsor
Institute Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021162

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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