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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030178
Receipt No. R000034177
Scientific Title Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Date of disclosure of the study information 2017/12/01
Last modified on 2018/06/01

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Basic information
Public title Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Acronym Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Scientific Title Development of non-invasive estimation method of cardiac output utilizing the lung-finger circulating time measurement.
Scientific Title:Acronym 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
1st name
Middle name
Last name Toshiaki Kadokami
Organization Fukuokaken Saiseikai Futsukaichi Hospital
Division name Cardiovascular Medicine
Zip code
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
1st name
Middle name
Last name Atsumi Hayashi
Organization Fukuokaken Saiseikai Futsukaichi Hospital
Division name Clinical research and education center
Zip code
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)

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
2017 Year 12 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
2017 Year 05 Month 02 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000034177

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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