UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023661 |
|---|---|
| Receipt number | 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 20:56:54 |
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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
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
agmcericu@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027235
| 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 |
