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
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
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
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
