UMIN-CTR Clinical Trial

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 Takeshi Middle name Last name Nomura
Organization	Tokyo Women's Medical University Hospital
Division name	Department of Intensive Care Unit
Zip code	162-8666
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 Masafumi Middle name Last name Idei
Organization	Tokyo Women's Medical University Hospital
Division name	Department of Intensive Care Unit
Zip code	162-8666
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	Tokyo Women's Medical University IRB
Address	8-1 Kawada-cho, Shinjuku, Tokyo, Japan
Tel	03-3353-8111
Email	ohta.megumi@twmu.ac.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	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	50
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	No longer recruiting
Date of protocol fixation	2018 Year 11 Month 24 Day
Date of IRB	2018 Year 11 Month 23 Day
Anticipated trial start date	2018 Year 12 Month 10 Day
Last follow-up date	2021 Year 03 Month 30 Day
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	2021 Year 12 Month 26 Day

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