Swan-Ganz Catheter InsertionSG cathNCT03929770
Swan-Ganz Catheter Insertion
A study testing with pause and without pause in people with Swan-Ganz Catheter Insertion, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Swan-Ganz Catheter Insertion
- What is being tested?
- with pause and without pause
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Apr 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who need to Swan-Ganz catheterization for heart surgeries
Who cannot join
- Who doesn't agree to enroll
- Who has thrombus in the heart or the vena cavas.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Boramae Hospital
Seoul, 07061
Jung-Man Lee, M.D.,Ph.D., 82-10-9553-0916, jungman007@gmail.com
About this study
Official title: 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?
Read the 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.
- Conditions
- Swan-Ganz Catheter Insertion
- Being tested
- with pause, without pause
- Keywords
- Swan-Ganz catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
with pauseProcedure or surgery
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 pauseProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| with pause | Active comparator | 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. Receives: Procedure: with pause |
| without pause | Experimental | 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. Receives: Procedure: without pause |
What is being measured
The primary outcome is the main question the study is designed to answer.
trial number (n)
trial number to success placement of Swan-Ganz catheter placement into the pulmonary artery.
Measured: during Swan-Ganz catheterization procedure
Success rate (%)
Success rate in placement of Swan-Ganz catheter placement into the pulmonary artery
Measured: during Swan-Ganz catheterization procedure
required time (seconds)
total time to success Swan-Ganz catheter placement into the pulmonary artery
Measured: during Swan-Ganz catheterization procedure
Secondary outcomes (2)
incidence of arrhythmia (n)
incidence of arrhythmia due to Swan-Ganz catheterization
Measured: during Swan-Ganz catheterization procedure
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
Measured: during Swan-Ganz catheterization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2019
- Study start29 Apr 2019 (estimated)
- Primary completion30 Mar 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Swan-Ganz Catheter InsertionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jung-Man Lee, Seoul National University Hospital
- Investigators
- Jung-Man Lee, M.D.,PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03929770
- Sponsor's protocol ID
- 10-2019-14
- Acronym
- SG cath
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 1 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pause at the Right Ventricle on Success Rate of Final Placement in Swan-Ganz Catheterization
- ClinicalTrials.gov ID
- NCT03929770
- Acronym / sponsor ID
- SG cath / 10-2019-14
- Conditions
- Swan-Ganz Catheter Insertion
- Keywords
- Swan-Ganz catheter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- 29 Apr 2019 (estimated)
- Primary completion
- 30 Mar 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 29 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with pause | Active comparator | Procedure: with pauseWhen 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 | Experimental | Procedure: without pauseWhen 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who need to Swan-Ganz catheterization for heart surgeries
Key exclusion criteria (2 listed)
- Who doesn't agree to enroll
- Who has thrombus in the heart or the vena cavas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| with pauseWhen 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 or surgery | with pause |
| without pauseWhen 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 or surgery | without pause |
Primary outcome
trial number (n)
Time frame: during Swan-Ganz catheterization procedure
trial number to success placement of Swan-Ganz catheter placement into the pulmonary artery.
Success rate (%)
Time frame: during Swan-Ganz catheterization procedure
Success rate in placement of Swan-Ganz catheter placement into the pulmonary artery
required time (seconds)
Time frame: during Swan-Ganz catheterization procedure
total time to success Swan-Ganz catheter placement into the pulmonary artery
2 secondary outcomes
incidence of arrhythmia (n)
Time frame: during Swan-Ganz catheterization procedure
direction of placement of Swan-Ganz catheter (n)
Time frame: during Swan-Ganz catheterization procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung-Man Lee, M.D.,PhD principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing with pause and without pause in people with Swan-Ganz Catheter Insertion, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Man Lee, M.D.,PhD. (+82-2-870-2513, jungman007@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
trial number (n) (time frame: during Swan-Ganz catheterization procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.