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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022597
Receipt No. R000024917
Scientific Title Comparison of insertion efficacy of ProSeal and i-gel under cricoid pressure
Date of disclosure of the study information 2016/06/06
Last modified on 2017/04/05

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Basic information
Public title Comparison of insertion efficacy of ProSeal and i-gel under cricoid pressure
Acronym Insertion of ProSeal or i-gel under cricoid pressure
Scientific Title Comparison of insertion efficacy of ProSeal and i-gel under cricoid pressure
Scientific Title:Acronym Insertion of ProSeal or i-gel under cricoid pressure
Region
Japan

Condition
Condition Patients who undergo general aneshtesia with SGD
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of ProSeal or i-gel insertion efficacy under cricoid pressure.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Insertion number and time
Key secondary outcomes Bronchofiberscope finding
postoperative pharyngeal pain and hoarseness

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) 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 Insertion of i-gel under cricoid pressure
Interventions/Control_2 Insertio of ProSeal under cricoid pressure
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
85 years-old >
Gender Male and Female
Key inclusion criteria Patients who undergo general anesthesia with SGD.
Key exclusion criteria Difficult airway anticipated patients.
Patients for emergency surgery.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Minami Toshiaki
Organization Osaka Medical College
Division name Dept of Anestheisology
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 Department of 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 06 Month 06 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
Insertion time was significantly smaller in i-gel trial than in the ProSeal trial.

Number of insertion was signficiantly smaller in the i-gel trial than in the ProSeal Trial.

The rate of appropriate position was significantly higher in the i-gel trial than in the ProSeal trial.
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 03 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 08 Day
Last follow-up date
2017 Year 04 Month 05 Day
Date of closure to data entry
2017 Year 04 Month 06 Day
Date trial data considered complete
2017 Year 04 Month 10 Day
Date analysis concluded
2017 Year 04 Month 12 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 03 Day
Last modified on
2017 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024917

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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