Swan-Ganz Catheter Insertion (SG cath)

April 28, 2019 updated by: Jung-Man Lee, Seoul National University Hospital

The Effect of Pause at the Right Ventricle on Success Rate of Final Placement in Swan-Ganz Catheterization

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 07061
        • Seoul National University Boramae Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Experimental: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of arrhythmia (n)
Time Frame: during Swan-Ganz catheterization procedure
incidence of arrhythmia due to Swan-Ganz catheterization
during Swan-Ganz catheterization procedure
direction of placement of Swan-Ganz catheter (n)
Time Frame: during Swan-Ganz catheterization procedure
direction of placement of Swan-Ganz catheter between the right pulmoary artery and the left pulmonary artery
during Swan-Ganz catheterization procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Jung-Man Lee, M.D.,PhD, SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 29, 2019

Primary Completion (Anticipated)

March 30, 2020

Study Completion (Anticipated)

April 30, 2020

Study Registration Dates

First Submitted

April 25, 2019

First Submitted That Met QC Criteria

April 26, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 28, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10-2019-14

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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