UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025507 |
|---|---|
| Receipt number | R000029358 |
| Scientific Title | Change of pure-tone audiometry before and after admission of intensive care unit |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2021/01/06 22:20:22 |
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Basic information
Public title
Change of pure-tone audiometry before and after admission of intensive care unit
Acronym
Hearing side-effect during intensive care
Scientific Title
Change of pure-tone audiometry before and after admission of intensive care unit
Scientific Title:Acronym
Hearing side-effect during intensive care
Region
| Japan |
Condition
Condition
Any disease requiring intensive care
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluated the change of audiometry between before and after intensive care
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of audiometry between before and after intensive care
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who had pure-tone audiometry within 5 years before Emergency Intensive Care Unit admit in Kurashiki Central Hospital
Key exclusion criteria
Patients will be excluded if they have unsuitable conditon for auditory (e.g. hypotention, need for high flow oxygen, any unstable vital sign, or severe dementia). Patients who can not sit during audiometry and will not be willing to participate to this study will be excluded
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Fujiwara |
Organization
Kurashiki central hospital
Division name
Otolaryngology
Zip code
710-8602
Address
1-1-1, Miwa, Kurashiki City, Okayama, Japan
TEL
086-422-0210
t.fujiwarabi@gmail.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Fujiwara |
Organization
Kurashiki central hospital
Division name
Otolaryngology
Zip code
710-8602
Address
1-1-1, Miwa, Kurashiki City, Okayama, Japan
TEL
086-422-0210
Homepage URL
t.fujiwarabi@gmail.com
Sponsor or person
Institute
Kurashiki central hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Kurashiki Central Hospital
Address
Kurashiki city, Miwa, 1-1-1
Tel
0864220210
tf14817@kchnet.or.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
| 2017 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
https://www.journals.elsevier.com/journal-of-otology/
Number of participants that the trial has enrolled
71
Results
121 ears of 71 patients included in analysis, and 21 ears had worse-hearing.
Results date posted
| 2021 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
male:female ratio, 35:36
mean age = 72.5
Participant flow
Identified by retrospective chart review
Adverse events
None
Outcome measures
Change of thresholds in pure-tone audiometry. 21 ears had worse-hearing.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 01 | Month | 03 | Day |
Last modified on
| 2021 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029358
| 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 |
