UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035199
Receipt number 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 2021/12/26 09:40:43

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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 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 or person

Institute

Tokyo Women's Medical University Hospital

Institute

Department

Personal name



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

Value
https://center6.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