Clinical Trial on the Safety and Efficacy of Transesophageal Echocardiography-Guided Combination Technique for Pulmonary Artery Catheter Placement

JRCT ID: jRCT1070220099

Registered date:31/01/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Scheduled cardiac surgery patients
• Date of first enrollment: 07/09/2022
• Target sample size: 120
• Study type: Observational

Outcome(s)

Primary Outcome

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

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Cardiovascular surgery patients at Kurume University Hospital who are scheduled cardiac surgery patients requiring pulmonary artery catheter placement will be eligible.

Exclude 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.

Related Information

• Primary Sponsor: jotaki shosaburo