UMIN-CTR Clinical Trial

Basic information
Public title	Non-invasive estimation of cardiac output by plethysmographic signal
Acronym	Non-invasive estimation of cardiac output by plethysmographic signal
Scientific Title	Non-invasive estimation of cardiac output by plethysmographic signal
Scientific Title:Acronym	Non-invasive estimation of cardiac output by plethysmographic signal
Region	Japan

Condition
Condition	Gastrointestinal cancer surgery
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Non-invasive estimation of cardiac output by plethysmographic signal
Basic objectives2	Others
Basic objectives -Others	Evaluation of accuracy
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Accuracy of estimated cardiac output compared with measured cardiac output.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients undergoing elective gastrointestinal cancer surgery with lapatoromy. Patients who is indicated intraoperative invasive arterial pressure monitoring.
Key exclusion criteria	Patients who have known conditions that may negatively affect the accuracy of cardiac output measurement with pulse contour method.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yoshifumi Middle name Last name Kotake
Organization	Toho University Ohashi Medical Center
Division name	Department of Anesthesiology
Zip code	1538515
Address	2-17-6, Ohashi, Meguro, Tokyo
TEL	03-3468-1251
Email	ykotake@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Yoshifumi Middle name Last name Kotake
Organization	Toho University Ohashi Medical Center
Division name	Department of Anesthesiology
Zip code	1538515
Address	2-17-6, Ohashi, Meguro, Tokyo
TEL	03-3568-1251
Homepage URL	http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
Email	ykotake@med.toho-u.ac.jp

Sponsor
Institute	Toho University Ohashi Medical Center, Department of Anesthesiology
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics comittee, Toho Unviersity Ohashi Medical Center
Address	2-22-36, Ohashi, Meguro, Tokyo
Tel	03-3468-1251
Email	secretary@oha.toho-u.ac.jp

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	東邦大学医療センター大橋病院(東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 10 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	42
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	under data analysis
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	2013 Year 04 Month 30 Day
Date of IRB	2012 Year 09 Month 27 Day
Anticipated trial start date	2013 Year 07 Month 01 Day
Last follow-up date	2016 Year 04 Month 30 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete	2016 Year 12 Month 31 Day
Date analysis concluded	2016 Year 12 Month 31 Day

Other
Other related information	Analysis of accuracy

Management information
Registered date	2013 Year 06 Month 10 Day
Last modified on	2021 Year 07 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012779