Swan-Ganz Catheter Insertion

Not Applicable

• Conditions: Swan-Ganz Catheter Insertion
• Interventions: Procedure: without pause; Procedure: with pause

• Registration Number: NCT03929770
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The goal of this prospective randomized controlled study is to investigate the effect of pause of advancement of the Swan-Ganz catheter, which is to check whether the Swan-Ganz catheter arrive exactly at the right ventricle or not, on success rate of final placement and required time in Swan-Ganz catheterization.

The question which the investigators are trying to answer is: Continuous advancement of Swan-Ganz catheter without intended pause in the right ventricle to check whether the Swan-Ganz catheter arrive exactly at the right ventricle will decrease the trial number and required time to success final placement of Swan-Ganz catheter?

Detailed Description

Many clinicians pause advancement of Swan-Ganz catheter to check whether the Swan-Ganz catheter arrive exactly at the right ventricle or not.

The hypothesis of this study is that the intended pause during advancement of Swan-Ganz catheter in the right ventricle induce failure in advancing of it into the pulmonary artery, and that it increase the required time for final placement of it into the pulmonary artery.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-26
• Last Update Submitted: 2019-04-28
• Study Start: 2019-04-29
• Study First Posted: 2019-04-29
• Last Update Posted: 2019-05-01
• Primary Completion: 2020-03-30
• Study Completion: 2020-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• The patients who need to Swan-Ganz catheterization for heart surgeries

Exclusion Criteria

• Who doesn't agree to enroll
• Who has thrombus in the heart or the vena cavas.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
without pause	without pause	When the practitioner or expert investigator recognize that the tip of Swan-Ganz catheter arrive in the right ventricle, the practitioner advance it continuously without pause to the pulmonary artery.
with pause	with pause	When the practitioner or expert investigator recognize that the tip of Swan-Ganz catheter arrive in the right ventricle, the practitioner pause the advancement for 10 sec. Next, the practitioner re-advance it to the pulmonary artery.

Primary Outcome Measures

Name	Time	Method
Success rate (%)	during Swan-Ganz catheterization procedure	Success rate in placement of Swan-Ganz catheter placement into the pulmonary artery
trial number (n)	during Swan-Ganz catheterization procedure	trial number to success placement of Swan-Ganz catheter placement into the pulmonary artery.
required time (seconds)	during Swan-Ganz catheterization procedure	total time to success Swan-Ganz catheter placement into the pulmonary artery

Secondary Outcome Measures

Name	Time	Method
direction of placement of Swan-Ganz catheter (n)	during Swan-Ganz catheterization procedure	direction of placement of Swan-Ganz catheter between the right pulmoary artery and the left pulmonary artery
incidence of arrhythmia (n)	during Swan-Ganz catheterization procedure	incidence of arrhythmia due to Swan-Ganz catheterization

Trial Locations

Locations (1)

Seoul National University Boramae Hospital; 🇰🇷 Seoul, Korea, Republic of