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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037147
Receipt No. 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 2020/06/10

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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
Email 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
Email kyong0203suk@yahoo.co.jp

Sponsor
Institute Anethesiology chiba University
Institute
Department

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
Email 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 Enrolling by invitation
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
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 06 Month 24 Day
Last modified on
2020 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042261

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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