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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023661
Receipt No. R000027235
Scientific Title The effectiveness of earplugs for preventing delirium in an intensive care unit in Japan.:a retrospective cohort study
Date of disclosure of the study information 2016/08/18
Last modified on 2016/08/18

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Basic information
Public title The effectiveness of earplugs for preventing delirium in an intensive care unit in Japan.:a retrospective cohort study
Acronym The effectiveness of earplugs for preventing delirium in an intensive care unit in Japan.:a retrospective cohort study
Scientific Title The effectiveness of earplugs for preventing delirium in an intensive care unit in Japan.:a retrospective cohort study
Scientific Title:Acronym The effectiveness of earplugs for preventing delirium in an intensive care unit in Japan.:a retrospective cohort study
Region
Japan

Condition
Condition delirium
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will evaluate the effectiveness of earplugs to prevent delirium in an ICU in Japan.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ICDSC(Intensive Care Delirium Screening Checklist)
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients admitted to the Emergency intensive care unit.
Key exclusion criteria Traumatic brain injury
Otolaryngology diseases
Cerebrovascular diseases
Dementia
Delirium at admission(ICDSC above 4)
Drug and alcohol addiction
Hepatic encephalopathy
Sedation was used(midazolam,propofol and dexmedetomidine)
Loss of consciousness(GCS less than 7 or JCS above 2)
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takehito Nota
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Emergency medical care center / Department of ER general medicine
Zip code
Address Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo 660-8550, Japan.
TEL 06-6480-7000
Email agmcericu@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takehito Nota
Organization Hyogo Prefectural Amagasaki General Medical Center
Division name Emergency medical care center / Department of ER general medicine
Zip code
Address 2-17-77,Higashi-naniwa cho,Amagasaki city,Hyogo,Japan
TEL 06-6480-7000
Homepage URL
Email agmcericu@gmail.com

Sponsor
Institute Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization none
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
Email

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 08 Month 18 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 Preinitiation
Date of protocol fixation
2016 Year 08 Month 17 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All Patients, meeting the inclusion criteria, who are admitted to the Emergency Intensive Care Unit in our hospital from January 1st,2016 to June 30th,2016.Patients are allowed not to use earplugs from January 1st to March 31st. The others are allowed to use earplugs from April 1st to June 30th.In the both groups, we evaluate with the difference of ICDSC between day1 and day3 after admission.

Management information
Registered date
2016 Year 08 Month 18 Day
Last modified on
2016 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027235

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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