UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041179 |
|---|---|
| Receipt number | R000047019 |
| Scientific Title | A study on visualization of patient's feelings and intentions using vital data |
| Date of disclosure of the study information | 2020/08/01 |
| Last modified on | 2023/01/24 07:56:23 |
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Basic information
Public title
A study on visualization of patient's feelings and intentions using vital data
Acronym
A study on visualization of patient's feelings and intentions using vital data
Scientific Title
A study on visualization of patient's feelings and intentions using vital data
Scientific Title:Acronym
A study on visualization of patient's feelings and intentions using vital data
Region
| Japan |
Condition
Condition
All patients admitted to the intensive care unit
Classification by specialty
| Surgery in general | Operative medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the method of visualizing patient's feelings and intentions using vital data.
Basic objectives2
Others
Basic objectives -Others
Predict pain in patients who cannot express their intentions using vital sign data and machine learning.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Accuracy for continuously predicting CPOT, an objective pain rating scale (AUROC)
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
All patients admitted to the intensive care unit who have at least five CPOT, RASS and CAM-ICU assessment and monitoring of electrocardiogram and arterial pressure more than 30 minutes before CAM-ICU to be evaluated.
Key exclusion criteria
(1) pregnancy; (2) organ transplantation; (3) cardiopulmonary bypass; (4) ventricular assist device (5) extracorporeal membrane oxygenation; (6) intra-aortic balloon pumping; or (7) decision not to resuscitate
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kobayashi |
Organization
Tohoku university
Division name
Department of anesthesiology and perioperative medicine
Zip code
9808572
Address
Seiryo-machi 2-1, Aoba, Sendai, Miyagi
TEL
0227177321
dynamis_air@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Kobayashi |
Organization
Tohoku university
Division name
Department of anesthesiology and perioperative medicine
Zip code
9808572
Address
Seiryo-machi 2-1, Aoba, Sendai, Miyagi
TEL
0227177321
Homepage URL
dynamis_air@yahoo.co.jp
Sponsor or person
Institute
Tohoku university graduate school of medicine, department of anesthesiology and perioperative medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo-machi 2-1, Aoba, Sendai, Miyagi
Tel
0227284105
med-kenkyo@grp.tohoku.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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All pain, sedation, and delirium evaluations during the study period will be recorded as CPOT, RASS, and CAM-ICU, respectively, and will be accumulated along with automatic acquisition of vital sign data.
Management information
Registered date
| 2020 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047019
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/08/18 | 退室サマリ 手術情報 手術_201501_201909.csv |
