UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015418 |
|---|---|
| Receipt number | R000017932 |
| Scientific Title | Survey of relationship between intubation and function of larynx |
| Date of disclosure of the study information | 2014/10/12 |
| Last modified on | 2024/01/26 11:08:05 |
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Basic information
Public title
Survey of relationship between intubation and function of larynx
Acronym
Survey of relationship between intubation and function of larynx
Scientific Title
Survey of relationship between intubation and function of larynx
Scientific Title:Acronym
Survey of relationship between intubation and function of larynx
Region
| Japan |
Condition
Condition
intubation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey of relationship between intubation and function of larynx
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hoarseness, recurrent nerve paralysis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who receive tracheal intubation during general anesthesia
Key exclusion criteria
patients that an agreement is not provided
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kawanishi |
Organization
Tokushima University
Division name
Department of Anesthesia
Zip code
7708503
Address
2-50-1, kuramoto cho, tokushima city, tokushima prefecture
TEL
0886337181
kawanishi.riyosuke@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Kawanishi |
Organization
Tokushima University
Division name
Department of Anesthesia
Zip code
7708503
Address
2-50-1, kuramoto cho, tokushima city, tokushima prefecture
TEL
0886337181
Homepage URL
kawanishi.riyosuke@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesia of Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesia of Tokushima University
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
Clinical Research Review Board of Tokushima University
Address
50-1 2 cho-me, Kuramoto-cho, tokushima-shi, Tokusima-ken, Japan
Tel
0886337958
brinshoshienk@tokushima-u.ac.jp
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
| 2014 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
https://tocms.ait231.tokushima-u.ac.jp/tocms/detail.php?id=2494&type=kk
Publication of results
Partially published
Result
URL related to results and publications
https://tocms.ait231.tokushima-u.ac.jp/tocms/detail_houkoku.php?rireki_id=2494&houkoku_id=2768&syous
Number of participants that the trial has enrolled
100
Results
Postoperative hoarseness is related to the relative diameter of the intubation tube
Results date posted
| 2024 | Year | 01 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients undergoing general anesthesia
Participant flow
Before and after intubation during induction of anesthesia, the laryngeal situation is observed with a video-laryngoscope and the percentage of the tube in the glottis is measured.
After completion of the procedure, the glottis is assessed for swelling with a fiberscope and hoarseness score is subsequently measured
Adverse events
None
Outcome measures
Relative tube diameter is associated with hoarseness in the immediate postoperative period
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2014 | Year | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017932
| 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 |
