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Swan-Ganz Catheter Insertion (SG cath)

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ClinicalTrials.gov Identifier: NCT03929770
Recruitment Status : Not yet recruiting
First Posted : April 29, 2019
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Jung-Man Lee, 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?


Condition or disease Intervention/treatment Phase
Swan-Ganz Catheter Insertion Procedure: with pause Procedure: without pause Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Pause at the Right Ventricle on Success Rate of Final Placement in Swan-Ganz Catheterization
Estimated Study Start Date : April 29, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : April 30, 2020

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.




Primary Outcome Measures :
  1. trial number (n) [ Time Frame: during Swan-Ganz catheterization procedure ]
    trial number to success placement of Swan-Ganz catheter placement into the pulmonary artery.

  2. Success rate (%) [ Time Frame: during Swan-Ganz catheterization procedure ]
    Success rate in placement of Swan-Ganz catheter placement into the pulmonary artery

  3. required time (seconds) [ Time Frame: during Swan-Ganz catheterization procedure ]
    total time to success Swan-Ganz catheter placement into the pulmonary artery


Secondary Outcome Measures :
  1. incidence of arrhythmia (n) [ Time Frame: during Swan-Ganz catheterization procedure ]
    incidence of arrhythmia due to Swan-Ganz catheterization

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929770


Contacts
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Contact: Jung-Man Lee, M.D.,PhD. +82-2-870-2513 jungman007@gmail.com

Locations
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Korea, Republic of
Seoul National University Boramae Hospital Not yet recruiting
Seoul, Korea, Republic of, 07061
Contact: Jung-Man Lee, M.D.,Ph.D.    82-10-9553-0916    jungman007@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
SMG-SNU Boramae Medical Center
Investigators
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Principal Investigator: Jung-Man Lee, M.D.,PhD SMG-SNU Boramae Medical Center

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Responsible Party: Jung-Man Lee, Clinical assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03929770     History of Changes
Other Study ID Numbers: 10-2019-14
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jung-Man Lee, Seoul National University Hospital:
Swan-Ganz catheter