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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041179
Receipt No. 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 2020/08/18

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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
Email 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
Email dynamis_air@yahoo.co.jp

Sponsor
Institute Tohoku university graduate school of medicine, department of anesthesiology and perioperative medicine
Institute
Department

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
Email 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 No longer recruiting
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
2022 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
2020 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.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


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