Catheter Related Complication3D GivenchyNCT04683302
3D Guided Internal Jugular Vein Catheterization
A study testing 3DUS biplanar catheterization and 2D US catheterization in people with Catheter Related Complication and Ultrasound; Complications, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
Central venous catheterization through the jugular vein is a standard procedure for cardiothoracic surgical patients. Ultrasound (US) guidance is preferred and compared to traditional landmark approach decreases complications and increases success rate. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Catheter Related Complication, Ultrasound; Complications
- What is being tested?
- 3DUS biplanar catheterization and 2D US catheterization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Mar 2021to 15 Sep 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective cardiothoracic surgery with need for central venous catheter placement
- written informed consent
Who cannot join
- no informed consent
- other site for central line placement (eg subclavian vein)
- emergency surgery
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Catharina Ziekenhuis Eindhoven
Eindhoven, North Brabant, 5623 EJ
About this study
Official title: 3D Biplane vs Conventional 2D Ultrasound Guided Internal Jugular VEin caNnulation in CardiotHoracic surgerY Patients
Central venous catheterization through the jugular vein is a standard procedure for cardiothoracic surgical patients. Ultrasound (US) guidance is preferred and compared to traditional landmark approach decreases complications and increases success rate. Both long and short axis views are used for obtaining access, both with their own advantages and shortcomings. Complications have also not completely diminished with the use of US. The investigators propose a new technique using 3D biplanar imaging, combining advantages from both long and short axis views in one image, enabling more successful procedures and a lower complication rate
Read the detailed description
Central venous catheters (CVC) are frequently placed in patients who are scheduled for cardiothoracic surgery (ICU). Ultrasound (US) guidance has consistently shown to not only improve success rate of procedures, but also to decrease complications with most benefit for the jugular vein. However, serious adverse events still occur despite US guidance Conventional two dimensional ultrasound (2D US) guided access if performed in either the short axis or long axis view, with both approaches having their own limitations. Using short axis view, the operator is never certain of the position of the needle tip as the shaft of the needle is not distinguishable from the tip in this view. Structures not (yet) visible in the US screen can already be punctured, or a vessel can be entered at a different position than preferred. A possible mechanism through which carotid artery puncture can happen is the posterior wall puncture4.
For long axis view, with proper technique the needle is viewed entirely during the procedure. However, this requires extensive experience and the overview of surrounding structures is lost.Multiple attempts at improving US guided venous access have been tried, such as oblique visualization or alternating short and long axis views but those approaches still have their shortcomings.
Three dimensional ultrasound (3D US) has a theoretical advantage of increased anatomical awareness, but evidence of improvement in needle based procedures is scarce.
Recently, a new 3D US probe is introduced which can address the above mentioned limitations of 2D US for access procedures.
The investigators hypothesize that this superior three dimensional awareness can improve needle placement during central venous catheterization, increasing success rates and potentially decreasing complications.
- Being tested
- 3DUS biplanar catheterization, 2D US catheterization
- Keywords
- ultrasound, internal jugular vein, cardiothoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3DUS biplanar catheterizationDevice
biplanar view of both short and long axis view of the internal jugular vein improves anatomical awareness and potentially improves safety of venous catheterization
2D US catheterizationDevice
2D short axis internal jugular vein catheterization
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | conventional 2D guided internal jugular vein catheterization Receives: Device: 2D US catheterization |
| intervention | Experimental | 3D biplanar guided internal jugular vein catheterization Receives: Device: 3DUS biplanar catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
first pass success
successful entry in internal jugular vein within one skin break and fluid motion
Measured: during procedure/surgery
Secondary outcomes (7)
imaging time
time from placing USprobe until start needling (in seconds)
Measured: during procedure/surgery
needling time
time from puncturing skin until access in vein (in seconds)
Measured: during procedure/surgery
number of skin punctures
total skin breaks needed before successful entry in vein
Measured: during procedure/surgery
number of needle withdrawals
redirections of needle >5mm without needing new skin breaks
Measured: during procedure/surgery
number of posterior wall punctures
puncture of posterior wall of jugular vein
Measured: during procedure/surgery
operator satisfaction
satisfaction of operator with visual feedback from US, rated on Likert Scale 1-5 with 1 no satisfaction at all and 5 totally satisfied
Measured: procedure/surgery
needle visibility
visualization of needle during procedure on US screen, rating from good - adequate - poor
Measured: procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start15 Mar 2021
- Primary completion15 Aug 2021
- Study completion15 Sep 2021
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 Catheter Related ComplicationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trial (RCT)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Collaborators
- Eindhoven University of Technology
- Responsible party
- Principal investigator, Harm Scholten, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683302
- Sponsor's protocol ID
- 3DJUG
- Acronym
- 3D Givenchy
- Status last verified
- Oct 2021
- First submitted
- 18 Dec 2020
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Scholten HJ, Meesters MI, Montenij LJ, Korsten EHM, Bouwman RA; 3DUI Study group. 3D biplane versus conventional 2D ultrasound imaging for internal jugular vein cannulation. Intensive Care Med. 2022 Feb;48(2):236-237. doi: 10.1007/s00134-021-06579-9. Epub 2021 Nov 22. No abstract available.
PubMed 34807306
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Biplane vs Conventional 2D Ultrasound Guided Internal Jugular VEin caNnulation in CardiotHoracic surgerY Patients
- ClinicalTrials.gov ID
- NCT04683302
- Acronym / sponsor ID
- 3D Givenchy / 3DJUG
- Keywords
- ultrasound, internal jugular vein, cardiothoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Collaborators
- Eindhoven University of Technology
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 24 Dec 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.
Central venous catheterization through the jugular vein is a standard procedure for cardiothoracic surgical patients. Ultrasound (US) guidance is preferred and compared to traditional landmark approach decreases complications and increases success rate. Both long and short axis views are used for obtaining access, both with their own advantages and shortcomings. Complications have also not completely diminished with the use of US. The investigators propose a new technique using 3D biplanar imaging, combining advantages from both long and short axis views in one image, enabling more successful procedures and a lower complication rate
Detailed description
Central venous catheters (CVC) are frequently placed in patients who are scheduled for cardiothoracic surgery (ICU). Ultrasound (US) guidance has consistently shown to not only improve success rate of procedures, but also to decrease complications with most benefit for the jugular vein. However, serious adverse events still occur despite US guidance Conventional two dimensional ultrasound (2D US) guided access if performed in either the short axis or long axis view, with both approaches having their own limitations. Using short axis view, the operator is never certain of the position of the needle tip as the shaft of the needle is not distinguishable from the tip in this view. Structures not (yet) visible in the US screen can already be punctured, or a vessel can be entered at a different position than preferred. A possible mechanism through which carotid artery puncture can happen is the posterior wall puncture4.
For long axis view, with proper technique the needle is viewed entirely during the procedure. However, this requires extensive experience and the overview of surrounding structures is lost.Multiple attempts at improving US guided venous access have been tried, such as oblique visualization or alternating short and long axis views but those approaches still have their shortcomings.
Three dimensional ultrasound (3D US) has a theoretical advantage of increased anatomical awareness, but evidence of improvement in needle based procedures is scarce.
Recently, a new 3D US probe is introduced which can address the above mentioned limitations of 2D US for access procedures.
The investigators hypothesize that this superior three dimensional awareness can improve needle placement during central venous catheterization, increasing success rates and potentially decreasing complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized clinical trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Device: 2D US catheterizationconventional 2D guided internal jugular vein catheterization |
| intervention | Experimental | Device: 3DUS biplanar catheterization3D biplanar guided internal jugular vein catheterization |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective cardiothoracic surgery with need for central venous catheter placement
- written informed consent
Key exclusion criteria (3 listed)
- no informed consent
- other site for central line placement (eg subclavian vein)
- emergency surgery
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 |
|---|---|---|
| 3DUS biplanar catheterizationbiplanar view of both short and long axis view of the internal jugular vein improves anatomical awareness and potentially improves safety of venous catheterization | Device | intervention |
| 2D US catheterization2D short axis internal jugular vein catheterization | Device | control |
Primary outcome
first pass success
Time frame: during procedure/surgery
successful entry in internal jugular vein within one skin break and fluid motion
7 secondary outcomes
imaging time
Time frame: during procedure/surgery
needling time
Time frame: during procedure/surgery
number of skin punctures
Time frame: during procedure/surgery
number of needle withdrawals
Time frame: during procedure/surgery
number of posterior wall punctures
Time frame: during procedure/surgery
operator satisfaction
Time frame: procedure/surgery
needle visibility
Time frame: procedure/surgery
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 5 Oct 2021.
- Derived from this study: PubMed 34807306Scholten HJ, Meesters MI, Montenij LJ, Korsten EHM, Bouwman RA; 3DUI Study group. 3D biplane versus conventional 2D ultrasound imaging for internal jugular vein cannulation. Intensive Care Med. 2022 Feb;48(2):236-237. doi: 10.1007/s00134-021-06579-9. Epub 2021 Nov 22. No abstract available.
- Individual participant dataSharing planned: No
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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.
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 3DUS biplanar catheterization and 2D US catheterization in people with Catheter Related Complication and Ultrasound; Complications, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
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 2 inclusion and 3 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 5 Oct 2021. 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 Netherlands. 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?
first pass success (time frame: during procedure/surgery). 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 NCT04683302, 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 5 Oct 2021.