UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of earplugs for preventing delirium in an intensive care unit in Japan.:a retrospective cohort study
Title of the study (Brief title)	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	Takehito Nota
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Emergency medical care center / Department of ER general medicine
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	Takehito Nota
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Emergency medical care center / Department of ER general medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 08 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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