UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the accuracy of non-invasive cardiac output monitoring after cardiovascular surgery
Title of the study (Brief title)	Evaluation of non-invasive cardiac output monitoring
Region	Japan

Condition
Condition	Patients undergoing cardiovascular surgery
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy and the accuracy of cardiac output and stroke volume variation monitored by esCCO (estimated Continuous Cardiac Output), which calculate these parameters noninvasively by pulse oximetry and electrocardiogram, as compared with pulmonary artery catheter and arterial pressure based cardiac output monitoring.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the chronological correlation between esCCO and pumonary artery catheter/arterial pressure based cardiac output monitoring regarding coadiac output and stroke vovume variation.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	cardiac output monitoring by pulse oxymetry
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	patients undergoing cardiovascular surgery
Key exclusion criteria	patients less than 20 years old
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroshi Morisaki
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Email	morisaki@z8.keio.jp

Public contact
Name of contact person	Takeshi Suzuki
Organization	Keio University School of Medicine
Division name	Department of Anesthesiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	03-3353-1211
Homepage URL
Email	takeshi-su@a7.keio.jp

Sponsor
Institute	Department of Anesthesiology, Keio University School of Medicine
Institute
Department

Funding Source
Organization	Nihon Kohden Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	none
Name of secondary funｄer(s)	none

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	慶應義塾大学病院

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 02 Month 15 Day
Anticipated trial start date	2014 Year 06 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 05 Month 17 Day
Last modified on	2019 Year 02 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016269