UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012287 |
|---|---|
| Receipt number | R000014367 |
| Scientific Title | Evaluation of pre-warming of the i-gel for insertion and ventilation quality |
| Date of disclosure of the study information | 2013/11/24 |
| Last modified on | 2014/03/18 12:56:23 |
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Basic information
Public title
Evaluation of pre-warming of the i-gel for insertion and ventilation quality
Acronym
Evaluation of prewarming for i-gel insertion
Scientific Title
Evaluation of pre-warming of the i-gel for insertion and ventilation quality
Scientific Title:Acronym
Evaluation of prewarming for i-gel insertion
Region
| Japan |
Condition
Condition
Patients for elective general anesthesia patients
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of pre-warming on i-gel insertion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Successful insertion of i-gel ventilation
Seal pressure
Key secondary outcomes
Ventilation volume
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
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
| Device,equipment |
Interventions/Control_1
Prewarming of i-gel
Interventions/Control_2
i-gel for normal use
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
Supraglottic Cases
Key exclusion criteria
Intubation cases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishihara Isao |
Organization
Hokusetsu General Hospital
Division name
Anesthesiology
Zip code
Address
Takatsuki Kitayanagawa 6-24
TEL
0726962121
xn6i-nshr@asahi-net.or.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
Takatsuki Daigakumachi 2-7
TEL
0726-84-6361
Homepage URL
koma21century@yahoo.co.jp
Sponsor or person
Institute
Hokusetsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokusetu general Hospital
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
| 2013 | Year | 11 | Month | 24 | 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
Prewarming of the i-gel at 42 degree enchanced the successful insertion of i-gel in muscle-relaxed patients.
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
| 2013 | Year | 11 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 23 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 18 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 18 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 18 | Day |
Other
Other related information
Postoperative pharyngeal pain was not seen in both patients.
Management information
Registered date
| 2013 | Year | 11 | Month | 13 | Day |
Last modified on
| 2014 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014367
