Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03929770
Other study ID # 10-2019-14
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 29, 2019
Est. completion date April 30, 2020

Study information

Verified date April 2019
Source Seoul National University Hospital
Contact Jung-Man Lee, M.D.,PhD.
Phone +82-2-870-2513
Email jungman007@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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?


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 112
Est. completion date April 30, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Korea, Republic of Seoul National University Boramae Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Seoul National University Hospital SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary trial number (n) trial number to success placement of Swan-Ganz catheter placement into the pulmonary artery. during Swan-Ganz catheterization procedure
Primary Success rate (%) Success rate in placement of Swan-Ganz catheter placement into the pulmonary artery during Swan-Ganz catheterization procedure
Primary required time (seconds) total time to success Swan-Ganz catheter placement into the pulmonary artery during Swan-Ganz catheterization procedure
Secondary incidence of arrhythmia (n) incidence of arrhythmia due to Swan-Ganz catheterization during Swan-Ganz catheterization procedure
Secondary direction of placement of Swan-Ganz catheter (n) direction of placement of Swan-Ganz catheter between the right pulmoary artery and the left pulmonary artery during Swan-Ganz catheterization procedure