UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046512 |
|---|---|
| Receipt number | R000053064 |
| Scientific Title | A prospective study on the relationship between frequency in vocalization and vocal cord size |
| Date of disclosure of the study information | 2021/12/28 |
| Last modified on | 2021/12/28 19:12:36 |
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Basic information
Public title
A prospective study on the relationship between frequency in vocalization and vocal cord size
Acronym
A study on the relationship between frequency in vocalization and vocal cord size
Scientific Title
A prospective study on the relationship between frequency in vocalization and vocal cord size
Scientific Title:Acronym
A study on the relationship between frequency in vocalization and vocal cord size
Region
| Japan |
Condition
Condition
noncardiac surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Based on data obtained in a prospective study, it is to construct a model that predicts vocal cord size from the frequency in vocalization.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
vocal cord size
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
non-cardiac surgery cases undergoing general anesthesia
Key exclusion criteria
emergency surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Okazaki |
| Middle name | |
| Last name | Zyunko |
Organization
Kimitsu Chuo Hospital
Division name
Anesthesiology
Zip code
2928535
Address
1010 Sakurai Kisarazushi
TEL
0438361071
tomoharu.ukiya.915@gmail.com
Public contact
Name of contact person
| 1st name | Ukiya |
| Middle name | |
| Last name | Tomoharu |
Organization
Kimitsu Chuo Hospital
Division name
Anesthesiology
Zip code
2928535
Address
1010 Sakurai Kisarazushi
TEL
0438361071
Homepage URL
tomoharu.ukiya.915@gmail.com
Sponsor or person
Institute
Kimitsu Chuo Hospital
Institute
Department
Personal name
Funding Source
Organization
Kimitsu Chuo Hospital
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
Kimitsu Chuo Hospital
Address
1010 Sakurai Kisarazushi
Tel
0438361071
tomoharu.ukiya.915@gmail.com
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
| 2021 | Year | 12 | Month | 28 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No
Management information
Registered date
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2021 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053064
