UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of vasoconstriction agent for FloTrac system (cardiac output measurement device by arterial blood pressure wave form)
Title of the study (Brief title)	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	Masashi Kawamoto
Organization	Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name	Department of Anesthesiology and Critical Care
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	Ryuji Nakamura
Organization	Division of Clinical Medical Science, Graduate School of Biomedical Sciences, Hiroshima University
Division name	Department of Anesthesiology and Critical Care
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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