UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008036
Receipt No. R000009405
Scientific Title Validation of cardiac output measuring using Vigileo-FloTrac system in cardiac surgery
Date of disclosure of the study information 2012/05/27
Last modified on 2013/11/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Validation of cardiac output measuring using Vigileo-FloTrac system in cardiac surgery
Acronym Validation of cardiac output measuring using Vigileo-FloTrac system in cardiac surgery
Scientific Title Validation of cardiac output measuring using Vigileo-FloTrac system in cardiac surgery
Scientific Title:Acronym Validation of cardiac output measuring using Vigileo-FloTrac system in cardiac surgery
Region
Japan

Condition
Condition Cardiac Disease
Greater Vessel Disease
Classification by specialty
Cardiology Anesthesiology Cardiovascular surgery
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validate the efficacy of cardiac output measurement with Vigileo-Flotrac system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare cardiac output values derived from Vigileo-FloTrac system with those derived from pulmonary artery catheters
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent cardiac surgery under general anesthesia
Key exclusion criteria Atrial fibrillation or atrial flutter
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuaki Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Anesthesiology
Zip code
Address 1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan
TEL 06-6645-2186
Email anesth@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuaki Tanaka
Organization Osaka City University Graduate School of Medicine
Division name Anesthesiology
Zip code
Address 1-5-7, Asahimachi, Abeno-ku, Osaka 545-8585 Japan
TEL 06-6645-2186
Homepage URL
Email anesth@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://bja.oxfordjournals.org/content/early/2013/03/08/bja.aet022.full.pdf
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
2011 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Bland and Altman analysis between cardiac output derived from Vigileo-FloTrac system and cardiac output derived from pulmonary arterial cactheters

Management information
Registered date
2012 Year 05 Month 27 Day
Last modified on
2013 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009405

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.