臨床研究等提出・公開システム

Scientific Title	Evaluation using transesophageal echocardiography during operation (Evaluation using transesophageal echocardiography during operation)
Public Title	Evaluation using transesophageal echocardiography during operation

Contact for Scientific Queries	Investigator Name	Junko Nakahira
	Investigator Organization	Osaka Medical College
	Address	2-7 Daigaku-machi, Takatsuki, Osaka, Japan
	TEL	+81-72-683-1221
	E-mail	ane052@osaka-med.ac.jp
Contact for Public Queries	Contact Name	Junko Nakahira
	Contact Organization	Osaka Medical College
	Address	2-7 Daigaku-machi, Takatsuki, Osaka, Japan
	TEL	+81-72-683-1221
	E-mail	ane052@osaka-med.ac.jp

Recruitment Status	COMPLETED

Date of First Enrollment		Dec. 06, 2013
Planned Number of Subjects		600
Nature of Investigation		Observational
Study Design	Description of Trial Design	Prospective observational study
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	Patients undergoing cardiovascular surgery with transesophageal echocardiography
	Exclusion Criteria	Patients with contraindications of transesophageal echocardiography
	Minimum Age	No limit
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		patients undergoing cardiovascular surgery
Intervention(s)		Intervention type: Name of intervention: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Evaluation of coronary arteries and mitral valve during mitral valve surgery Evaluation in relation between aortic valve and coronary arteries
Secondary Outcome(s)		basic echocardiographic parameters of 2D and 3D TEE

Primary Sponsor	Junko Nakahira
Secondary Sponsor

Sources of funding	self-sustaining fund

Name of Ethics Committee	Ethics committee Osaka Medical College
Address
TEL
FAX
E-Mail	rinri@osaka-med.ac.jp
Ethics Committee Website
Committee Approval Number	1319
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Nov. 11, 2013

-->

Secondary Study ID	JMA-IIA00153
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	May. 09, 2018	(this page)	Changes
1	Dec. 05, 2013	Detail

List of change history