臨床研究等提出・公開システム

Date of registration	Jan. 31, 2023
Last modified on	Aug. 23, 2023
Trial ID	jRCT1070220099

Scientific Title	Clinical Trial on Pressure Waveform Monitoring and Combined with Transesophageal Echocardiography Guidance for Pulmonary Artery Catheter Placement
Public Title	Clinical Trial on the Safety and Efficacy of Transesophageal Echocardiography-Guided Combination Technique for Pulmonary Artery Catheter Placement

Contact for Scientific Queries	Name	jotaki shosaburo
	Affiliation	Kurume University Hospital
	Address	67 Asahi-cho, Kurume City, Fukuoka Prefecture, Japan
	Telephone	+81-942-35-3311
	E-mail	joutaki_shouzaburou@kurume-u.ac.jp
Contact for Public Queries	Name	jotaki shosa
	Affiliation	Kurume University Hospital
	Address	67 Asahi-cho, Kurume City, Fukuoka Prefecture, Japan
	Telephone	+81-942353311
	E-mail	joutaki_shouzaburou@kurume-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Jan. 31, 2023
Actual date of first enrollment		Sept. 07, 2022
Target sample size		120
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	Cardiovascular surgery patients at Kurume University Hospital who are scheduled cardiac surgery patients requiring pulmonary artery catheter placement will be eligible.
	Exclusion Criteria	Patients who are deemed unsuitable as research subjects by the principal investigator and research assistants. Patients scheduled for puncture from a site other than the right internal jugular vein. Patients scheduled for fluoroscopic implantation.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Scheduled cardiac surgery patients
Primary Outcome(s)		Primary endpoint: Success rate of placement. Definition of successful catheterization: In the conventional method, a successful catheterization was defined as the catheter was successfully implanted into the pulmonary artery by pressure waveform monitoring alone. For the combined method, success is defined as catheter placement up to the pulmonary artery by TEE and pressure waveform monitoring alone. Successful placement is confirmed by chest radiograph immediately after catheter placement. Definition of failure of catheter placement: Failure of catheter placement to the pulmonary artery, procedure taking more than 5 minutes, use of fluoroscopy, change of operator, or reinsertion for any reason after radiographs are taken.
Secondary Outcome(s)		Secondary endpoints: procedure time, complications. Procedure time: The time from insertion of the pulmonary arter catheter into the sheath and placement of the balloon to the end of the procedure. Complications: Arrhythmia (consecutive ventricular extrasystoles, three or more consecutive ventricular extrasystoles, consecutive non-sustained ventricular tachycardia, sustained ventricular tachycardia, ventricular fibrillation), catheter nodule formation, cardiac perforation, cardiac tamponade, pulmonary artery rupture, pneumothorax, hemothorax are defined as complications.

Primary Sponsor	Kurume University Hospital

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Kurume University Medical Ethics Committee
Address	67 Asahi-cho, Kurume City, Fukuoka Prefecture, Japan, Fukuoka
Telephone	+81-942-65-3749
E-Mail	crb_aro@kurume-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 01, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Aug. 23, 2023	(this page)	Changes
1	Jan. 31, 2023	Detail

List of change history