UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025135 |
|---|---|
| Receipt number | R000028227 |
| Scientific Title | Effects of support method of tracheal tube in general anesthesia on postoperative sore throat |
| Date of disclosure of the study information | 2016/12/05 |
| Last modified on | 2021/11/24 18:12:20 |
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Basic information
Public title
Effects of support method of tracheal tube in general anesthesia on postoperative sore throat
Acronym
Effects of support method of tracheal tube in general anesthesia on postoperative sore throat
Scientific Title
Effects of support method of tracheal tube in general anesthesia on postoperative sore throat
Scientific Title:Acronym
Effects of support method of tracheal tube in general anesthesia on postoperative sore throat
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The patients who underwent surgery under general anesthesia requiring tracheal intubation to the subject at the University of Tsukuba University Hospital, incidence of postoperative sore throat in support two methods of tracheal tube and a comparative study whether the difference in the degree occurs do. We support the method of tracheal tube was hypothesized that does not affect the onset of post-operative sore throat. So to speak, in which the present study for the safety check is carried out.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
If familiar with the support method of the tracheal tube is induced sore throat occur, there is a need to review the method of supporting the tracheal tube.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To support the addition of curved to the tracheal tube
Interventions/Control_2
Support without the addition of curved tracheal tube
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
Key exclusion criteria
Except for the head and neck surgery,smoker,Detain a stomach tube and Cases that could not be intubated in one trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Satumae |
Organization
University of Tsukuba medical clinical medicine
Division name
anesthesia
Zip code
Address
2-1-1 Tenkubo Tsukuba, Ibaraki prefecture
TEL
029-853-3092
tsuu@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Musashi Yahagi |
Organization
Tsukuba University Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-1-1 Tenkubo Tsukuba, Ibaraki prefecture
TEL
029-853-3092
Homepage URL
musasum0710@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba Anesthesiology Department
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
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 | 12 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
Results
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 | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 04 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028227
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
