UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Title of the study (Brief title)	Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1. The lung-to-finger circulation time (LFCT) is defined as the time from start of rebreathing after deoxygenation by a temporary breath-holding to the nadir of the oxygen saturation. To compare LFCT and cardiac index (CI) obtained from another method. 2. The accuracy of cardiac index (CI) measurement using LFCT method by a oxygen saturation sensor which we have developed together with Fuji Xerox Co., Ltd. will be confirmed by the simultaneous measurements utilizing the 2 methods.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship will be analyzed between CI obtained by cardiac magnetic resonance (CMR) or cardiac catheterization and LFCT that is measured during the patients awake or measured from the data of overnight polysomnography. The accuracy of the oxygen saturation (SpO2) obtained from our co-developed system will be confirmed by comparison with those obtained from the oxygen values from the conventional measurement of arterial oxygen partial pressure during the catheterization procedure or SpO2 from a commercially available SPO2 monitor device.
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Fx sensor
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	The study subjects will be recruited from the patients who will be admitted to the cardiovascular department in Saiseikai Futsukaichi hospital to undergo the cardiac catheterization or CMR measurement.
Key exclusion criteria	The patients who have shunt for hemodialysis or who cannot perform or are not suitable for breath-holding like patients with dementia or acute myocardial infarction will be excluded.
Target sample size	30

Research contact person
Name of lead principal investigator	Toshiaki Kadokami
Organization	Fukuokaken Saiseikai Futsukaichi Hospital
Division name	Cardiovascular Medicine
Address	3-13-1, Yu-machi, Chikushino-shi, Fukuoka
TEL	092-923-1551
Email	t-kadokami@saiseikai-futsukaichi.org

Public contact
Name of contact person	Atsumi Hayashi
Organization	Fukuokaken Saiseikai Futsukaichi Hospital
Division name	Clinical research and education center
Address	3-13-1, Yu-machi, Chikushino-shi, Fukuoka
TEL	092-923-1551
Homepage URL
Email	s-futsu6@saiseikai-futsukaichi.org

Sponsor
Institute	Fukuokaken Saiseikai Futsukaichi Hospital Cardiovascular Medicine
Institute
Department

Funding Source
Organization	Fuji Xerox Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 02 Day
Anticipated trial start date	2017 Year 05 Month 16 Day
Last follow-up date	2018 Year 02 Month 05 Day
Date of closure to data entry	2018 Year 02 Month 08 Day
Date trial data considered complete	2018 Year 02 Month 13 Day
Date analysis concluded	2018 Year 03 Month 31 Day

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

Management information
Registered date	2017 Year 11 Month 30 Day
Last modified on	2018 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034177