UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037147 |
|---|---|
| Receipt number | R000042261 |
| Scientific Title | A prospective observational study on intraoperative hypotension prediction model creation by transthoracic echocardiography |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2021/04/30 13:04:54 |
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Basic information
Public title
A prospective observational study on intraoperative hypotension prediction model creation by transthoracic echocardiography
Acronym
Intraoperative hypotension prediction model creation by transthoracic echocardiography
Scientific Title
A prospective observational study on intraoperative hypotension prediction model creation by transthoracic echocardiography
Scientific Title:Acronym
Intraoperative hypotension prediction model creation by transthoracic echocardiography
Region
| Japan |
Condition
Condition
noncardiac surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Based on reliable data obtained in a prospective observational study, it is to construct hypotension development prediction model during general anesthesia using objective exercise tolerance, RCRI, and transthoracic echocardiography findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hypotension during introduction
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
non-cardiac and cardiac surgery adult cases undergoing general anesthesia at Chiba University Hospital
Key exclusion criteria
1 minor
2 emergency surgery
3 slow introduction
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Son |
| Middle name | |
| Last name | Kyongsuk |
Organization
Chiba university hospital
Division name
Anesthesiology
Zip code
2608677
Address
1-8-1 inohana chuuouku chibashi
TEL
0432227171
kyong0203suk@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Son |
| Middle name | |
| Last name | Kyongsuk |
Organization
Chiba University Hospital
Division name
Anesthesiology
Zip code
2608677
Address
1-8-1 inohana chuuouku chibashi
TEL
0432227171
Homepage URL
kyong0203suk@yahoo.co.jp
Sponsor or person
Institute
Anethesiology chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Chiba University IRB
Address
inohana chuuouku chbashi
Tel
0432227171
igaku-rinri@office.chiba-u.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
| 2019 | Year | 07 | 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
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 06 | Month | 24 | Day |
Last modified on
| 2021 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042261
