臨床研究等提出・公開システム

Date of registration	Oct. 20, 2021
Last modified on	July. 02, 2022
Trial ID	jRCT1032210381

Scientific Title	New method for non-invasive measurement of cardiac output with vector flow mapping
Public Title	New method for non-invasive measurement of cardiac output with vector flow mapping

Contact for Scientific Queries	Name	Inui Tomohiko
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba, Chiba, Japan
	Telephone	+81-43-222-7171
	E-mail	nuinui5762@yahoo.co.jp
Contact for Public Queries	Name	Kanda Tomoyoshi
	Affiliation	Chiba University Hospital
	Address	1-8-1 Inohana, Chuo-ku, Chiba, Chiba, Japan
	Telephone	+81-43-222-7171
	E-mail	t.kanda0808@gmail.com

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 08, 2021
Actual date of first enrollment		Oct. 24, 2021
Target sample size		12
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Patients who require cardiovascular surgery monitored with Swan-Ganz catheter.
	Exclusion Criteria	1. Patients who undergo emergency surgery. 2. Patients with continuous arrhythmia. (i.e. chronic atrial fibrillation) 3. Other patients judged to be inappropriate by the principal investigator or investigator
	Age Minimum	20age old over
	Age Maximum	90age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Cardiovascular disease
Intervention(s)		Transthoracic echocardiography will be performed before and after surgery. Before surgery, it will be performed when patients are admitted to our hospital, and when Swan-Ganz catheter is inserted in operating room. After surgery, it will be performed on admission to the intensive care unit (ICU), 2 hours, and 4 hours after admission to the ICU, and when patients are extubed.
Health Condition(s) Keyword		Cardiovascular disease
Primary Outcome(s)		We will compare measurements of cardiac output, with Swan-Ganz catheter and with vector flow mapping.
Secondary Outcome(s)		We will compare measurements of cardiac output, with Swan-Ganz catheter and with VTI method and biplane method.

Primary Sponsor	Department of Cardiovascular Surgery, Chiba University HospitalChiba University Hospital

Secondary Sponsor

Source of Monetary Support	JSPS KAKENHI Grant
Secondary Sponsor	Not applicable

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	Oct. 08, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	July. 02, 2022	(this page)	Changes
1	Oct. 20, 2021	Detail

List of change history