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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035199
Receipt No. R000040107
Scientific Title Correlation between Patient State Index (PSI) and Richmond Agitation-Sedation Scale (RASS) in patients sedated in Intensive Care Unit
Date of disclosure of the study information 2018/12/10
Last modified on 2018/12/10

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Basic information
Public title Correlation between Patient State Index (PSI) and Richmond Agitation-Sedation Scale (RASS) in patients sedated in Intensive Care Unit
Acronym Correlation between PSI and RASS in patients sedated in ICU
Scientific Title Correlation between Patient State Index (PSI) and Richmond Agitation-Sedation Scale (RASS) in patients sedated in Intensive Care Unit
Scientific Title:Acronym Correlation between PSI and RASS in patients sedated in ICU
Region
Japan

Condition
Condition Patients requiring sedation for mechanical ventilation in ICU
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the correlation between Patient State Index (PSI) and Richmond Agitation - Sedation Scale (RASS) in patients sedated in ICU.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the correlation between Patient State Index (PSI) and Richmond Agitation - Sedation Scale (RASS)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients requiring sedation for mechanical ventilation in the ICU of Tokyo Women's Medical University Hospital
2.Patients who got adequate explanation for participation in this study and written consent was obtained
Key exclusion criteria 1.Patient who underwent craniotomy
2.Patients diagnosed with drug addiction
3.Patients whose acute stage of intracranial disease is indicated
4.Patients with consciousness disturbance (14 GCS or less) before sedation drug administration
5.Patients with severe liver dysfunction
6.Patients with severe renal dysfunction
7.Patients who can not adequately affix the SedLine sensor to the forehead
8.Patients in whom muscle relaxant effect remained
9.Patients whose research managers judged inappropriate as research subjects
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Nomura
Organization Tokyo Women's Medical University Hospital
Division name Department of Intensive Care Unit
Zip code
Address 8-1 Kawada-cho, Shinjuku, Tokyo, Japan
TEL 03-3353-8111
Email nomur@crocus.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Idei
Organization Tokyo Women's Medical University Hospital
Division name Department of Intensive Care Unit
Zip code
Address 8-1 Kawada-cho, Shinjuku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email masafumi203@gmail.com

Sponsor
Institute Tokyo Women's Medical University 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
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
2018 Year 12 Month 10 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We evaluate the correlation between Patient State Index (PSI) and Richmond Agitation - Sedation Scale (RASS) in patients sedated in ICU. In addition, we record and analyze the patient's background and clinical course.

Management information
Registered date
2018 Year 12 Month 10 Day
Last modified on
2018 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040107

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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