UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017490 |
|---|---|
| Receipt number | R000019842 |
| Scientific Title | Evaluation of supraglottic insertion efficacy by the pillow height difference |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2015/12/06 11:37:11 |
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Basic information
Public title
Evaluation of supraglottic insertion efficacy by the pillow height difference
Acronym
Pillow height and SGD insertion
Scientific Title
Evaluation of supraglottic insertion efficacy by the pillow height difference
Scientific Title:Acronym
Pillow height and SGD insertion
Region
| Japan |
Condition
Condition
Patient who undergo general anesthesia with supraglottic device
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the pillow height effect for supraglottic device insertion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insertion success rate, sealing pressure
Key secondary outcomes
Postoperative pharyngeal pain, hoarseness, subjective difficulty of insertion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
SGD insertion with one pillow
Interventions/Control_2
SGD insertion with three pillow
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
Patient who undergo general anesthesia with supraglottic device
Key exclusion criteria
Patient who are contraindicated for supraglottic device
Target sample size
70
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
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Komasawa Nobuyasu |
Organization
Osaka Medical College
Division name
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
| 2015 | Year | 05 | Month | 11 | 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 effecicay ofi-gel did not significantly differ between high and low pillow.
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
| 2015 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pharyngeal pain and hoarseness did not differ significantly too.
Management information
Registered date
| 2015 | Year | 05 | Month | 11 | Day |
Last modified on
| 2015 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019842
