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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025507
Receipt No. 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 2019/07/07

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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
Email 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
Email t.fujiwarabi@gmail.com

Sponsor
Institute Kurashiki central hospital
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Enrolling by invitation
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
2023 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
2019 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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