Central Venous CathetersNCT05877794
Does the Central Venous Puncture Needle Need to be 7 cm?
A study testing central venous catheter insertion in people with Central Venous Catheters, run by Ajou University School of Medicine.
Trial summary
The central venous catheter (CVC) has been used for the first time in clinical use in 1921 and has been used worldwide by 2023. Although there are differences between studies, it is reported that side effects occur in approximately 5-20% of patients undergoing CVC. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Central Venous Catheters
- What is being tested?
- central venous catheter insertion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 27 May 2023to 31 Jul 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who need CVC catheter for operation
Who cannot join
- Obesity (BMI > 35)
- wound or infection exist at the puncture site
- History of long term catheter placment in the IJV
- Abnormally small size or deformity of the IJV
- Past history of difiiculty in CVC catheterization
- If the IJV is located at a depth of 3cm or more from theskin on ultrasound evaluation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does the Central Venous Puncture Needle Need to be 7 cm? ; Safety and Usefulness of Needle Length Adjustment Method Using Suture Wing
The central venous catheter (CVC) has been used for the first time in clinical use in 1921 and has been used worldwide by 2023. Although there are differences between studies, it is reported that side effects occur in approximately 5-20% of patients undergoing CVC. Common side effects include hematoma, venous puncture, arterial puncture, and pneumothorax, and horner syndrome is also reported in 5% of cases. In particular, in the case of the internal jugular vein (IJV), the possibility of puncture of the internal carotid artery is higher than that of other sites, and the puncture level also varies depending on the depth of needle insertion, which in some cases can cause very serious side effects. The incidence rate of side effects depends on the method of inserting the CVC and the skill of the operator. Previous method approached the IJV using the anatomy ladmark with the blind Seldinger technique, recently, as the use of ultrasound has become more common.
Ultra sound guided CVC insertion tecnique reduce the incidence of side effect. However, there are still major complications exist because less experiance operator inserts needle too deep without caution and only depends on the image of sonography.
Read more
Currently, the length of the needle commonly used in the CVC catheter set is 7 cm. In general, the depth from the skin to the IJV is within 1.5cm on either the right or the left, and under the premise that the needle insertion angle is 45 degrees, the distance from the skin to the IJV is within 2cm. Based on this, in previous studies, it was announced that the length of the needle required for IJV access was less than 4 cm.
The purpose of this study is to study the usefulness and safety of the method of sono-guided CVC catheter insertion by fixing the needle at a position 4 cm from the needle tip by placing the suture wing (18G, single catheter set).
- Conditions
- Central Venous Catheters
- Being tested
- central venous catheter insertion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
central venous catheter insertionDevice
All patients were under trendlenburg position (10 degrees) and disinfected for CVC catheterization. After attaching 2 suture wings of 18G single catheter set to the insertion needle in the 7 Fr or 8 Fr central catheter set, check the IJV to be punctured with an ultrasonic probe. The IJV is punctured using a cross sectional image confirmed at the cricoid cartilage level. After confirming the needle tip on the ultrasound image and blood coming out, the guide wire is mounted on the IJV and then a CVC catheter (arrow international INC) ., USA) is inserted. All actions are performed by a specialist who has more than 30 CVC catheterization experiences using ultrasound, and the occurrence of side effects and the time from puncture to guide wire entry are recorded by another researcher. After the procedure, the researcher who directly performed the procedure records the difficulty or difference compared to when using a conventional needle that does not have a suture wing installed.
| Study group | Role | What they receive |
|---|---|---|
| wing group | Experimental | Not described Receives: Device: central venous catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difficulty of catheterization
It would be evaluated by the operator who performed the catheterization. The severity of difficulty would be determined by total sum of the following scores.
- needle tip visibility with sono: good (0), not good (1), bad(2)
- blood aspiration was during needle withdrawal :1
- Number of attempt :1 ,2, 3
Total score would be ranged from 0 to 6
Measured: through study completion, an average of 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start27 May 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CathetersStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiyoung Yoo, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877794
- Sponsor's protocol ID
- AJIRB-MED-INT-22-188
- Status last verified
- May 2023
- First submitted
- 17 Jun 2022
- Last updated
- 26 May 2023
- 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 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Central Venous Puncture Needle Need to be 7 cm? ; Safety and Usefulness of Needle Length Adjustment Method Using Suture Wing
- ClinicalTrials.gov ID
- NCT05877794
- Acronym / sponsor ID
- AJIRB-MED-INT-22-188
- Conditions
- Central Venous Catheters
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 27 May 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 26 May 2023 (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 central venous catheter (CVC) has been used for the first time in clinical use in 1921 and has been used worldwide by 2023. Although there are differences between studies, it is reported that side effects occur in approximately 5-20% of patients undergoing CVC. Common side effects include hematoma, venous puncture, arterial puncture, and pneumothorax, and horner syndrome is also reported in 5% of cases. In particular, in the case of the internal jugular vein (IJV), the possibility of puncture of the internal carotid artery is higher than that of other sites, and the puncture level also varies depending on the depth of needle insertion, which in some cases can cause very serious side effects. The incidence rate of side effects depends on the method of inserting the CVC and the skill of the operator. Previous method approached the IJV using the anatomy ladmark with the blind Seldinger technique, recently, as the use of ultrasound has become more common.
Ultra sound guided CVC insertion tecnique reduce the incidence of side effect. However, there are still major complications exist because less experiance operator inserts needle too deep without caution and only depends on the image of sonography.
Currently, the length of the needle commonly used in the CVC catheter set is 7 cm. In general, the depth from the skin to the IJV is within 1.5cm on either the right or the left, and under the premise that the needle insertion angle is 45 degrees, the distance from the skin to the IJV is within 2cm. Based on this, in previous studies, it was announced that the length of the needle required for IJV access was less than 4 cm.
The purpose of this study is to study the usefulness and safety of the method of sono-guided CVC catheter insertion by fixing the needle at a position 4 cm from the needle tip by placing the suture wing (18G, single catheter set).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| wing group | Experimental | Device: central venous catheter insertion |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who need CVC catheter for operation
Key exclusion criteria (6 listed)
- Obesity (BMI > 35)
- wound or infection exist at the puncture site
- History of long term catheter placment in the IJV
- Abnormally small size or deformity of the IJV
- Past history of difiiculty in CVC catheterization
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 |
|---|---|---|
| central venous catheter insertionAll patients were under trendlenburg position (10 degrees) and disinfected for CVC catheterization. After attaching 2 suture wings of 18G single catheter set to the insertion needle in the 7 Fr or 8 Fr central catheter set, check the IJV to be punctured with an ultrasonic probe. The IJV is punctured using a cross sectional image confirmed at the cricoid cartilage level. After confirming the needle tip on the ultrasound image and blood coming out, the guide wire is mounted on the IJV and then a CVC catheter (arrow international INC) ., USA) is inserted. All actions are performed by a specialist who has more than 30 CVC catheterization experiences using ultrasound, and the occurrence of side effects and the time from puncture to guide wire entry are recorded by another researcher. After the procedure, the researcher who directly performed the procedure records the difficulty or difference compared to when using a conventional needle that does not have a suture wing installed. | Device | wing group |
Primary outcome
The difficulty of catheterization
Time frame: through study completion, an average of 10 minutes
It would be evaluated by the operator who performed the catheterization. The severity of difficulty would be determined by total sum of the following scores. 1. needle tip visibility with sono: good (0), not good (1), bad(2) 2. blood aspiration was during needle withdrawal :1 3. Number of attempt :1 ,2, 3 Total score would be ranged from 0 to 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing central venous catheter insertion in people with Central Venous Catheters, run by Ajou University School of Medicine.
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: status not confirmed, as of the sponsor's last update on 26 May 2023. 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 ji young yoo (01056902104, anesyoo@aumc.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difficulty of catheterization (time frame: through study completion, an average of 10 minutes). 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 26 May 2023.