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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023020
Receipt No. R000024999
Scientific Title Comparison of i-gel size 3 or 4 in patients under general anesthesia; randomized controlled trial
Date of disclosure of the study information 2016/07/05
Last modified on 2016/10/08

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Basic information
Public title Comparison of i-gel size 3 or 4 in patients under general anesthesia; randomized controlled trial
Acronym i-gel size 3 or 4 in patients under general anesthesia; randomized controlled trial
Scientific Title Comparison of i-gel size 3 or 4 in patients under general anesthesia; randomized controlled trial
Scientific Title:Acronym i-gel size 3 or 4 in patients under general anesthesia; randomized controlled trial
Region
Japan

Condition
Condition Patients who undergo general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of i-gel3 and i-gel 4 for effective airway management during general anesthesia in patients 50-60kg.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sealing pressure
Key secondary outcomes insertion time insertion number
postoperative pharygeal pain hoarseness

relative position of glottis and i-ge

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 application of i-gel3 to i-gel4
Interventions/Control_2 application of i-gel4 to -gel3
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients undergoing general anesthesia with SGD
Key exclusion criteria Patients who is contraindicated for SGD usage.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Minami
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7 Daigaku-machi, Takatsuk city
TEL 0726-84-6361
Email ane022@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyasu Komasawa
Organization Osaka Medical College
Division name Anesthesiology
Zip code
Address 2-7Daigaku-machi, Takatsuki city
TEL 0726-84-6361
Homepage URL
Email ane078@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical college
Institute
Department

Funding Source
Organization Osaka Medical College
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 07 Month 05 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
Sealing pressure was higher in size3 than size 4.

Insertion time was smaller in size3 than size4.

Insertion number was smaller in size than size 4. 
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 07 Month 04 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 10 Day
Last follow-up date
2016 Year 10 Month 08 Day
Date of closure to data entry
2016 Year 10 Month 11 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Abnormality of relative position to the glottis was higher in size4 than in size3.

Management information
Registered date
2016 Year 07 Month 04 Day
Last modified on
2016 Year 10 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024999

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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