UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022597 |
|---|---|
| Receipt number | 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 20:25:55 |
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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
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
ane078@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024917
