UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057134 |
|---|---|
| Receipt number | R000065309 |
| Scientific Title | Activity report on introducing early warning scores to quickly identify patients at risk of sudden deterioration in SCU |
| Date of disclosure of the study information | 2025/08/31 |
| Last modified on | 2025/04/01 18:10:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Activity report on introducing early warning scores to quickly identify patients at risk of sudden deterioration in SCU
Acronym
Activity report on introducing early warning scores to quickly identify patients at risk of sudden deterioration in SCU
Scientific Title
Activity report on introducing early warning scores to quickly identify patients at risk of sudden deterioration in SCU
Scientific Title:Acronym
Activity report on introducing early warning scores to quickly identify patients at risk of sudden deterioration in SCU
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Neurosurgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Early extraction of sudden changes by observing NPi values with NEWS2 and digital pupillometry.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of sudden changes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Observation of NEWS2 and NPi values by digital pupillometer once daily during the entire period of admission to the SCU, increasing to three times daily when NEWS2 is five points or more.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients admitted to the SCU during the period
Key exclusion criteria
sedated patient
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | DAISUKE |
| Middle name | |
| Last name | SARUGAKU |
Organization
KYORIN UNIVERSITY HOSPITAL
Division name
storke care unit
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka City, Tokyo
TEL
0422-47-5511
daisuke-0803@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | DAISUKE |
| Middle name | |
| Last name | SARUGAKU |
Organization
KYORIN UNIVERSITY HOSPITAL
Division name
stroke care unit
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka City, Tokyo
TEL
0422-47-5511
Homepage URL
daisuke-0803@ks.kyorin-u.ac.jp
Sponsor or person
Institute
KYORIN UNIVERSITY
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
KYORIN UNIVERSITY HOSPITAL
Address
6-20-2 Shinkawa, Mitaka City, Tokyo
Tel
0422-47-5511
daisuke-0803@ks.kyorin-u.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
| 2025 | Year | 08 | Month | 31 | 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
| 2025 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 26 | Day |
Last modified on
| 2025 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065309
