Catheterization, Central VenousNCT03077802
Ultrasound Guided Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique
A study testing Modified Seldinger technique, Experienced group, Seldinger technique, Experienced group and Modified Seldinger technique, Inexperienced group in people with Catheterization, Central Venous, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators intend to compare the Seldinger technique and modified Seldinger technique on success rate and complications during central venous catheterization by a prospective, randomized, controlled study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Catheterization, Central Venous
- What is being tested?
- Modified Seldinger technique, Experienced group, Seldinger technique, Experienced group and Modified Seldinger technique, Inexperienced group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to 28 Feb 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient scheduled for surgery and internal jugular vein central catheterization
Who cannot join
- Patient who doesn't agree to the study
- Catheterization site inflammation
- Contralateral diaphragmatic dysfunction
- Anatomic anomalies of carotid artery or vein
- Previous neck surgical history
- Recent (less than 1 month) right internal jugular vein central catheterization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Ultrasound Guided Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique
The investigators intend to compare the Seldinger technique and modified Seldinger technique on success rate and complications during central venous catheterization by a prospective, randomized, controlled study. The investigators are planning to compare both techniques in both experienced (anesthesiologist board member) and non-experienced practitioners (first and second-grade resident).
Read the detailed description
Unintended arterial puncture and local hematoma formation are the most common complications during internal jugular vein central venous catheterization. Other serious complications like pseudoaneurysm, arteriovenous fistula, arterial dissection, thrombosis, embolism are also possible. These complications mostly occur by mechanical trauma or injury when advancing needle back and forth to puncture internal jugular vein. Placement of guidewire or dilator can also cause mechanical trauma or injury around the vessel.
Because internal jugular vein collapses easily during needle advance, anterior and posterior wall of the vessel can be punctured simultaneously. Posterior wall puncture can increase the risk of complications of the catheterization. Delicate puncture of the vessel and stable fixation of the needle after puncture are important to reduce overall number of catheterization attempts, increase success rate, reduce complications.
Seldinger technique(thin-wall needle technique) is commonly used procedure to obtain safe access to central vein. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.
When using Seldinger technique, it is important to fix the needle firmly with hand until the guidewire is placed into the vessel lumen. If hand fixation is not stable, needle tip can migrate from the lumen, can pierce the vessel wall, and carotid artery puncture, and local hematoma formation might occur. Even if there is no evidence of complications, when blood regurgitation fails, overall number of vessel puncture attempts would increase and it is expected that rate of complications of the catheterization would increase.
When using modified Seldinger technique, guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively in early step of the catheterization. Therefore, it is expected that stability of the fixation improves, success rate of the catheterization increase, and complications of the catheterization decrease. But there is no high level of evidence yet, and still decision to use which technique is based on experience of the operator.
The investigators are going to compare the Seldinger technique and modified Seldinger technique on success rate and complications during central venous catheterization by prospective, randomized, controlled study.
In addition, any difference in success rate and complications between the two techniques may be different depending on the experience of the practitioners. Therefore, the investigators also plan to compare the two techniques between experienced and non-experienced practitioners.
The success rate and complications between the two techniques may also be different depending on the long and short-axis techniques. As subgroup analyses, we intend to investigate whether there is a difference between Seldinger and modified Seldinger technique according to the experience of the operator or long or short axis approach.
- Conditions
- Catheterization, Central Venous
- Being tested
- Modified Seldinger technique, Experienced group, Seldinger technique, Experienced group, Modified Seldinger technique, Inexperienced group, Seldinger technique, Inexperienced group, Long-axis technique
- Keywords
- Seldinger technique, Modified Seldinger technique, Complication, Success rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Seldinger technique, Experienced groupOther
This is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques.
Seldinger technique, Experienced groupOther
This is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques.
Modified Seldinger technique, Inexperienced groupOther
This is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques.
Seldinger technique, Inexperienced groupOther
This is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques.
Long-axis techniqueOther
Ultrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach.
Short-axis techniqueOther
Ultrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach.
| Study group | Role | What they receive |
|---|---|---|
| Modified Seldinger technique, Experienced group | Experimental | Under ultrasound-guide, we will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by experienced practitioner who were defined as board-certified anesthesiologist staffs and had experience of more than 50 central venous catheterizations in both techniques. Receives: Other: Modified Seldinger technique, Experienced group; Other: Long-axis technique; Other: Short-axis technique |
| Seldinger technique, Experienced group | Active comparator | Under ultrasound-guide, the desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by experienced practitioner who were defined as board-certified anesthesiologist staffs and had experience of more than 50 central venous catheterizations in both techniques. Receives: Other: Seldinger technique, Experienced group; Other: Long-axis technique; Other: Short-axis technique |
| Modified Seldinger technique, Inexperienced group | Experimental | Under ultrasound-guide, we will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by inexperienced practitioner who were junior residents and had experience of less than 50 central venous catheterizations in both techniques. Receives: Other: Modified Seldinger technique, Inexperienced group; Other: Long-axis technique; Other: Short-axis technique |
| Seldinger technique, Inexperienced group | Active comparator | Under ultrasound-guide, the desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by inexperienced practitioner who were junior residents and had experience of less than 50 central venous catheterizations in both techniques. Receives: Other: Seldinger technique, Inexperienced group; Other: Long-axis technique; Other: Short-axis technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of attempts of needle advance for successful venous puncture
number of attempts of needle advance (number of needling attempt)
Measured: 5 min after internal jugular vein catheterization
Secondary outcomes (10)
incidence of arterial puncture
incidence of arterial puncture during internal jugular vein catheterization
Measured: 5 min after internal jugular vein catheterization
incidence of local hematoma
incidence of jugular venous hematoma during internal jugular vein catheterization
Measured: 5 min after internal jugular vein catheterization
incidence of pneumothorax
incidence of pneumothorax during internal jugular vein
Measured: 5 min after internal jugular vein catheterization
incidence of hemothorax
incidence of hemothorax during internal jugular vein
Measured: 5 min after internal jugular vein catheterization
Time to successful jugular venous catheterization
incidence of hemothorax during internal jugular vein (overall procedure time)
Measured: 5 min after internal jugular vein catheterization
number of attempts of needle advance
number of attempts of needle advance
Measured: 5 min after internal jugular vein catheterization
number of attempts of catheter advance
number of attempts of needle advance (only in modified Seldinger group)
Measured: 5 min after internal jugular vein catheterization
incidence of successful central venous catheterization
incidence of successful central venous catheterization (success defined as completion of catheterization within three attempts of needle advance)
Measured: 5 min after internal jugular vein catheterization
grade of resistance during dilator insertion
grade of resistance during dilator insertion (grade 1: easy, grade 2: moderate, grade 3: difficult, use of blade for skin incision
Measured: 5 min after internal jugular vein catheterization
number of attempts of guidewire advance
number of attempts of guidewire advance through the lumen of needle or guidewire sheath after desired vessel is punctured
Measured: 5 min after internal jugular vein catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startOct 2015
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheterization, Central VenousStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Ho Kim, MD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077802
- Sponsor's protocol ID
- 1506-126-684
- Status last verified
- Dec 2019
- First submitted
- 8 Mar 2017
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoon HK, Hur M, Cho H, Jeong YH, Lee HJ, Yang SM, Kim WH. Effects of practitioner's experience on the clinical performance of ultrasound-guided central venous catheterization: a randomized trial. Sci Rep. 2021 Mar 24;11(1):6726. doi: 10.1038/s41598-021-86322-y.
PubMed 33762662
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Ultrasound Guided Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique
- ClinicalTrials.gov ID
- NCT03077802
- Acronym / sponsor ID
- 1506-126-684
- Conditions
- Catheterization, Central Venous
- Keywords
- Seldinger technique, Modified Seldinger technique, Complication, Success rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 13 Mar 2017 (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 investigators intend to compare the Seldinger technique and modified Seldinger technique on success rate and complications during central venous catheterization by a prospective, randomized, controlled study. The investigators are planning to compare both techniques in both experienced (anesthesiologist board member) and non-experienced practitioners (first and second-grade resident).
Detailed description
Unintended arterial puncture and local hematoma formation are the most common complications during internal jugular vein central venous catheterization. Other serious complications like pseudoaneurysm, arteriovenous fistula, arterial dissection, thrombosis, embolism are also possible. These complications mostly occur by mechanical trauma or injury when advancing needle back and forth to puncture internal jugular vein. Placement of guidewire or dilator can also cause mechanical trauma or injury around the vessel.
Because internal jugular vein collapses easily during needle advance, anterior and posterior wall of the vessel can be punctured simultaneously. Posterior wall puncture can increase the risk of complications of the catheterization. Delicate puncture of the vessel and stable fixation of the needle after puncture are important to reduce overall number of catheterization attempts, increase success rate, reduce complications.
Seldinger technique(thin-wall needle technique) is commonly used procedure to obtain safe access to central vein. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.
When using Seldinger technique, it is important to fix the needle firmly with hand until the guidewire is placed into the vessel lumen. If hand fixation is not stable, needle tip can migrate from the lumen, can pierce the vessel wall, and carotid artery puncture, and local hematoma formation might occur. Even if there is no evidence of complications, when blood regurgitation fails, overall number of vessel puncture attempts would increase and it is expected that rate of complications of the catheterization would increase.
When using modified Seldinger technique, guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively in early step of the catheterization. Therefore, it is expected that stability of the fixation improves, success rate of the catheterization increase, and complications of the catheterization decrease. But there is no high level of evidence yet, and still decision to use which technique is based on experience of the operator.
The investigators are going to compare the Seldinger technique and modified Seldinger technique on success rate and complications during central venous catheterization by prospective, randomized, controlled study.
In addition, any difference in success rate and complications between the two techniques may be different depending on the experience of the practitioners. Therefore, the investigators also plan to compare the two techniques between experienced and non-experienced practitioners.
The success rate and complications between the two techniques may also be different depending on the long and short-axis techniques. As subgroup analyses, we intend to investigate whether there is a difference between Seldinger and modified Seldinger technique according to the experience of the operator or long or short axis approach.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Modified Seldinger technique, Experienced group | Experimental | Other: Modified Seldinger technique, Experienced group, Other: Long-axis technique, Other: Short-axis techniqueUnder ultrasound-guide, we will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by experienced practitioner who were defined as board-certified anesthesiologist staffs and had experience of more than 50 central venous catheterizations in both techniques. |
| Seldinger technique, Experienced group | Active comparator | Other: Seldinger technique, Experienced group, Other: Long-axis technique, Other: Short-axis techniqueUnder ultrasound-guide, the desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by experienced practitioner who were defined as board-certified anesthesiologist staffs and had experience of more than 50 central venous catheterizations in both techniques. |
| Modified Seldinger technique, Inexperienced group | Experimental | Other: Modified Seldinger technique, Inexperienced group, Other: Long-axis technique, Other: Short-axis techniqueUnder ultrasound-guide, we will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by inexperienced practitioner who were junior residents and had experience of less than 50 central venous catheterizations in both techniques. |
| Seldinger technique, Inexperienced group | Active comparator | Other: Seldinger technique, Inexperienced group, Other: Long-axis technique, Other: Short-axis techniqueUnder ultrasound-guide, the desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by inexperienced practitioner who were junior residents and had experience of less than 50 central venous catheterizations in both techniques. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient scheduled for surgery and internal jugular vein central catheterization
Key exclusion criteria (6 listed)
- Patient who doesn't agree to the study
- Catheterization site inflammation
- Contralateral diaphragmatic dysfunction
- Anatomic anomalies of carotid artery or vein
- Previous neck surgical history
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 |
|---|---|---|
| Modified Seldinger technique, Experienced groupThis is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques. | Other | Modified Seldinger technique, Experienced group |
| Seldinger technique, Experienced groupThis is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques. | Other | Seldinger technique, Experienced group |
| Modified Seldinger technique, Inexperienced groupThis is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques. | Other | Modified Seldinger technique, Inexperienced group |
| Seldinger technique, Inexperienced groupThis is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques. | Other | Seldinger technique, Inexperienced group |
| Long-axis techniqueUltrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach. | Other | Modified Seldinger technique, Experienced group, Modified Seldinger technique, Inexperienced group, Seldinger technique, Experienced group, Seldinger technique, Inexperienced group |
| Short-axis techniqueUltrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach. | Other | Modified Seldinger technique, Experienced group, Modified Seldinger technique, Inexperienced group, Seldinger technique, Experienced group, Seldinger technique, Inexperienced group |
Primary outcome
number of attempts of needle advance for successful venous puncture
Time frame: 5 min after internal jugular vein catheterization
number of attempts of needle advance (number of needling attempt)
10 secondary outcomes
incidence of arterial puncture
Time frame: 5 min after internal jugular vein catheterization
incidence of local hematoma
Time frame: 5 min after internal jugular vein catheterization
incidence of pneumothorax
Time frame: 5 min after internal jugular vein catheterization
incidence of hemothorax
Time frame: 5 min after internal jugular vein catheterization
Time to successful jugular venous catheterization
Time frame: 5 min after internal jugular vein catheterization
number of attempts of needle advance
Time frame: 5 min after internal jugular vein catheterization
number of attempts of catheter advance
Time frame: 5 min after internal jugular vein catheterization
incidence of successful central venous catheterization
Time frame: 5 min after internal jugular vein catheterization
grade of resistance during dilator insertion
Time frame: 5 min after internal jugular vein catheterization
number of attempts of guidewire advance
Time frame: 5 min after internal jugular vein catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 33762662Yoon HK, Hur M, Cho H, Jeong YH, Lee HJ, Yang SM, Kim WH. Effects of practitioner's experience on the clinical performance of ultrasound-guided central venous catheterization: a randomized trial. Sci Rep. 2021 Mar 24;11(1):6726. doi: 10.1038/s41598-021-86322-y.
- Individual participant dataSharing planned: No
Related trials for Catheterization, Central Venous
RecruitingObservational study
Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients
Frailty, Cardiac Surgery
Enrolling by invitationObservational study
Ultrasound Guidance vs Landmark Technique for Internal Jugular Vein Catheterization
Central Vein Catheter, Ultrasound
Enrolling by invitationObservational study
Ultrasound Guidance vs. Landmark Technique for Catheter Malposition in IJV Catheterization
Catheter Malposition, Central Venous Catheterization
Not yet recruitingObservational study
Ultrasound Assessment of Internal Jugular Vein for Cannulation and Venous Pressure Prediction
Vascular Access, Elevated Jugular Venous Pressure
Active, not recruitingObservational study
Effect of Central Venous Catheterization on Brain Pressure in Acute Brain Injury Patients
Acute Brain Injury, Traumatic Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Seldinger technique, Experienced group, Seldinger technique, Experienced group and Modified Seldinger technique, Inexperienced group in people with Catheterization, Central Venous, 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 6 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: finished, as of the sponsor's last update on 12 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of attempts of needle advance for successful venous puncture (time frame: 5 min after internal jugular vein catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03077802, which also lists 1 linked publication.
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 12 Dec 2019.