Central Venous CatheterizationNCT04279808
Adequate Insertion Depth of Dilator During Central Venous Catheterization
A study testing dilator depth in people with Central Venous Catheterization, run by Seoul National University Hospital.
Trial summary
For safe central catheterization, clinicians must be aware of adequate dilator insertion depth not to directly dilate the venous wall. The purpose of the study is to find out adequate insertion depth of the dilator during central venous catheterization through the internal jugular vein with the aid of real-time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Venous Catheterization
- What is being tested?
- dilator depth
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Jan 2021
- 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
- adult patients requiring central venous catheterization through the right internal jugular vein
Who cannot join
- suspicion for infection of the right neck site
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adequate Insertion Depth of Dilator During Central Venous Catheterization Through the Right Internal Jugular Vein
For safe central catheterization, clinicians must be aware of adequate dilator insertion depth not to directly dilate the venous wall. The purpose of the study is to find out adequate insertion depth of the dilator during central venous catheterization through the internal jugular vein with the aid of real-time ultrasonography.
Read the detailed description
This randomized controlled trial is to compare the distance between the skin puncture site and the outside of anterior wall of the internal jugular vein measured by real-time ultrasonography with the conventional method which is routinely used in common clinical practice.
- Conditions
- Central Venous Catheterization
- Being tested
- dilator depth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dilator depthProcedure or surgery
For soft tissue dilation just after guidewire insertion in central venous catheterization through the right internal jugular vein, investigators will measure the distance between the skin puncture site and outside of anterior wall of the vein with real-time ultrasonography in the measured depth group. Next, practitioner will insert the dilator by the measured length and continue to insert the central venous catheter. For the conventional group as a control group, practitioner will perform the central venous catheterization with a manner used routinely by the practitioner.
| Study group | Role | What they receive |
|---|---|---|
| measured distance | Experimental | In the modified Seldinger's maneuver, after guide-wire insertion into the right internal jugular vein, "we will measure the distance between the skin puncture site and the outside of anterior wall of the jugular vein. Next, we will insert the dilator on the guidewire by the measured length." Receives: Procedure: dilator depth |
| conventional method | No intervention | In the modified Seldinger's maneuver, after guide-wire insertion into the right internal jugular vein, "we will insert the dilator on the guidewire as commonly used method of the practitioners." |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematoma realted with the dilator
hematoma from the vascular wall puncture by the dilator
Measured: 1 Day (on the study day for each patient)
Secondary outcomes (1)
distance between skin puncture site and the outside of the anterior wall of the internal jugular vein
distance between skin puncture site and the outside of the anterior wall of the internal jugular vein which will be measured by real-time ultrasonography
Measured: 1 Day (on the study day for each patient)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterizationStudies 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
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 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
- Sponsor
- Investigators
- Jung-Man Lee, M.D.,PhD, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279808
- Sponsor's protocol ID
- 10-2019-3
- Status last verified
- Feb 2020
- First submitted
- 18 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequate Insertion Depth of Dilator During Central Venous Catheterization Through the Right Internal Jugular Vein
- ClinicalTrials.gov ID
- NCT04279808
- Acronym / sponsor ID
- 10-2019-3
- Conditions
- Central Venous Catheterization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 21 Feb 2020 (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.
For safe central catheterization, clinicians must be aware of adequate dilator insertion depth not to directly dilate the venous wall. The purpose of the study is to find out adequate insertion depth of the dilator during central venous catheterization through the internal jugular vein with the aid of real-time ultrasonography.
Detailed description
This randomized controlled trial is to compare the distance between the skin puncture site and the outside of anterior wall of the internal jugular vein measured by real-time ultrasonography with the conventional method which is routinely used in common clinical practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| measured distance | Experimental | Procedure: dilator depthIn the modified Seldinger's maneuver, after guide-wire insertion into the right internal jugular vein, "we will measure the distance between the skin puncture site and the outside of anterior wall of the jugular vein. Next, we will insert the dilator on the guidewire by the measured length." |
| conventional method | No intervention | –In the modified Seldinger's maneuver, after guide-wire insertion into the right internal jugular vein, "we will insert the dilator on the guidewire as commonly used method of the practitioners." |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients requiring central venous catheterization through the right internal jugular vein
Key exclusion criteria (1 listed)
- suspicion for infection of the right neck site
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 |
|---|---|---|
| dilator depthFor soft tissue dilation just after guidewire insertion in central venous catheterization through the right internal jugular vein, investigators will measure the distance between the skin puncture site and outside of anterior wall of the vein with real-time ultrasonography in the measured depth group. Next, practitioner will insert the dilator by the measured length and continue to insert the central venous catheter. For the conventional group as a control group, practitioner will perform the central venous catheterization with a manner used routinely by the practitioner. | Procedure or surgery | measured distance |
Primary outcome
hematoma realted with the dilator
Time frame: 1 Day (on the study day for each patient)
hematoma from the vascular wall puncture by the dilator
1 secondary outcome
distance between skin puncture site and the outside of the anterior wall of the internal jugular vein
Time frame: 1 Day (on the study day for each patient)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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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
Questions about this trial
What is this clinical trial studying?
A study testing dilator depth in people with Central Venous Catheterization, run by Seoul National University Hospital.
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 1 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 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
hematoma realted with the dilator (time frame: 1 Day (on the study day for each patient)). 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 6 Mar 2020; AzTrials last refreshed its copy on 2 Nov 2026.