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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010936
Receipt No. R000010080
Scientific Title The effect of vasoconstriction agent for FloTrac system (cardiac output measurement device by arterial blood pressure wave form)
Date of disclosure of the study information 2013/07/01
Last modified on 2018/12/26

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Basic information
Public title The effect of vasoconstriction agent for FloTrac system (cardiac output measurement device by arterial blood pressure wave form)
Acronym The effect of vasoconstriction agent for FloTrac system
Scientific Title The effect of vasoconstriction agent for FloTrac system (cardiac output measurement device by arterial blood pressure wave form)
Scientific Title:Acronym The effect of vasoconstriction agent for FloTrac system
Region
Japan

Condition
Condition Elective surgery patient over 20 yrs
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to estimate the difference of measurements between objective device (FloTrac system) and control device (Ordinary cardiac output monitoring devices).
Basic objectives2 Others
Basic objectives -Others Estimation of the accuracy of medical used device.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The difference of cardiac output measurements between FloTrac system and Ordinary cardiac output monitoring devices in anesthesia.
Key secondary outcomes The existence of cardiac output measurements change in FloTrac system and Ordinary cardiac output monitoring devices in anesthesia.

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 Planned arterial catheterization.
Planned usage of vasoconstriction agent if necessary.
Pulmonary artery catheter and/or transesophageal ultrasonic cardiography planned.
Written informed consent
Key exclusion criteria Diagnosis of moderate or severe arterial regargitation.(Except the patients who are expected to be corrected aortic regurgitation during surgery.)
Treated by intra aortic baloon pumping.
Pregnant woman.
Body mass index more than 40.
Body weight less than 40kg.
Participation to other studies which influence the measurements of this study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Kawamoto
Organization Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name Department of Anesthesiology and Critical Care
Zip code
Address 1-2-3,Kasumi,Minami-ku,Hiroshima
TEL 081-082-256-3234
Email r-nacamura@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryuji Nakamura
Organization Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name Department of Anesthesiology and Critical Care
Zip code
Address 1-2-3,Kasumi,Minami-ku,Hiroshima
TEL 081-082-256-3234
Homepage URL
Email r-nacamura@hiroshima-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Critical Care, Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 広島大学病院

Other administrative information
Date of disclosure of the study information
2013 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
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
2014 Year 03 Month 31 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information None

Management information
Registered date
2013 Year 06 Month 12 Day
Last modified on
2018 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010080

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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