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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025130
Receipt No. R000028895
Scientific Title Study of prediction of hypotension at induction of general anesthesia by internal jugular vein diameter measured by ultrasonography
Date of disclosure of the study information 2016/12/02
Last modified on 2019/08/28

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Basic information
Public title Study of prediction of hypotension at induction of general anesthesia by internal jugular vein diameter measured by ultrasonography
Acronym Study of prediction of hypotension at induction of general anesthesia by internal jugular vein diameter measured by ultrasonography
Scientific Title Study of prediction of hypotension at induction of general anesthesia by internal jugular vein diameter measured by ultrasonography
Scientific Title:Acronym Study of prediction of hypotension at induction of general anesthesia by internal jugular vein diameter measured by ultrasonography
Region
Japan

Condition
Condition Hypotension during the induction of general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to clarify whether internal jugular vein measurement by ultrasonography before induction of general anesthesia can be a predictor of hypotension accompanying induction of general anesthesia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The occurrence of hypotension 5 minutes after propofol administration (defined as mean blood pressure less than 60 mmHg or more than 30% decrease from baseline).
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 Adult patients planned to undergo general anesthesia
Key exclusion criteria Emergency surgery, history of heart failure, moderate or more valvular heart disease, peripheral artery disease, aortic disease, left ventricular ejection fraction <40%, American Society of Anesthesiologists' Physical Status III
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Kenta
Middle name
Last name Okamura
Organization Yokohama City University Hospital
Division name Department of Anesthesiology
Zip code 236-0004
Address 9, Fukuura 3 - chome, Kanazawa ku Yokohama City
TEL 045-787-2800
Email dr.kenta1@gmail.com

Public contact
Name of contact person
1st name Kenta
Middle name
Last name Okamura
Organization Yokohama City University Hospital
Division name Department of Anesthesiology
Zip code 236-0004
Address 9, Fukuura 3 - chome, Kanazawa ku Yokohama City
TEL 045-787-2800
Homepage URL
Email dr.kenta1@gmail.com

Sponsor
Institute Yokohama City University
Institute
Department

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 Yokohama City University Certified Institutional Review Board
Address 9, Fukuura 3 - chome, Kanazawa ku Yokohama City
Tel 045-370-7627
Email rinri@yokohama-cu.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
2016 Year 12 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 100
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
2016 Year 09 Month 25 Day
Date of IRB
2016 Year 11 Month 14 Day
Anticipated trial start date
2016 Year 12 Month 05 Day
Last follow-up date
2019 Year 08 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 12 Month 02 Day
Last modified on
2019 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028895

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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