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

Clinical Trial on Pressure Waveform Monitoring and Combined with Transesophageal Echocardiography Guidance for Pulmonary Artery Catheter Placement

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1070220099

Enrollment

120

Registered

2023-01-31

Start date

2022-09-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Scheduled cardiac surgery patients

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public Contactshosa jotaki

Kurume University Hospital

joutaki_shouzaburou@kurume-u.ac.jp+81-942353311

Outcome results