Complications; Catheter, MechanicalELUSIVENCT05513378
Ultrasound-guided Subclavian Vein Catheterisation With a Needle Guide
A study testing Needle guide in people with Complications; Catheter, Mechanical and Catheterization, Central Venous, run by Thomas Kander at 1 site in Sweden.
Trial summary
OBJECTIVES The primary objective is to compare if the addition of a needle guide can reduce the number of central venous catheter (CVC) insertions with >1 skin puncture in ultrasound-guided catheterization of the subclavian vein using the long-axis approach with an in-plane needling technique. Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Complications; Catheter, Mechanical, Catheterization, Central Venous
- What is being tested?
- Needle guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 8 Nov 2022to 30 Sep 2025
- 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 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in need of a central venous catheter .
- Clinical indication for the subclavian route which includes expected time of use >5 days.
- Signed informed consent.
Who cannot join
- Patient is deemed unsuitable for cannulation of the subclavian vein, based on a pre-procedural US examination by the operator, or due to unacceptable patient risk in case of mechanical complication (e.g., severe respiratory failure).
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Intensive and Perioperative Care. Skåne University Hospital. Lund
Lund, Skåne County, 22185
About this study
Official title: A Randomized Controlled Trial Comparing In-line Ultrasound Guided Subclavian Vein Catheterization With or Without Needle Guide.
OBJECTIVES The primary objective is to compare if the addition of a needle guide can reduce the number of central venous catheter (CVC) insertions with >1 skin puncture in ultrasound-guided catheterization of the subclavian vein using the long-axis approach with an in-plane needling technique.
Secondary objectives include if this addition 1) decreases the frequency of mechanical complications (defined as bleeding, arterial puncture, arterial catheterization, nerve injury, pneumothorax), 2) increases the time when the needle is visible, 3) decreases the time until successful vessel punction, 4) decreases the number of needle redirections during the insertion, and 5) a comparison between the two groups regarding number of failed catheterizations.
Read more
DESIGN This is a prospective, randomised, controlled, parallel intervention study. Patients will be enrolled at Skåne University Hospital in Lund, Sweden. The trial is investigator-initiated and non-commercial.
POPULATION AND INTERVENTION Adults (18 years of age or older) in need of a subclavian CVC for any reason and able to give written informed consent will be included in the study provided no exclusion criteria is fulfilled.
OUTCOMES Primary outcome will be number of CVC insertions with >1 skin puncture. Secondary outcomes include comparison between the two groups regarding 1) the frequency of mechanical complications, 2) proportion of the insertion-time when the needle is visible on the ultrasound (US) screen, 3) time to successful vessel punction, 4) the number of needle redirections during the insertion, 5) number of failed catheterisations, 6) Feasibility of the needle guide evaluated with a questionair to the operators at the end of the study.
- Being tested
- Needle guide
- Keywords
- diagnostic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle guideDevice
Also called The Ultra-Pro II™ Needle Guide, model C8-5 Philips
Please see the arm/group description
| Study group | Role | What they receive |
|---|---|---|
| With Needle Guide | Experimental | A needle guide adapted to a micro-convex ultrasound probe will be used in ultrasound-guided catheterisation of the subclavian vein using the long-axis approach with an in-plane needling technique Receives: Device: Needle guide |
| Without Needle Guide | No intervention | A micro-convex ultrasound probe without needle guide will be used in ultrasound-guided catheterisation of the subclavian vein using the long-axis approach with an in-plane needling technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subclavian catheter insertions with >1 skin puncture
Number of subclavian catheter insertions with >1 skin puncture
Measured: During the central venous catheterization, up to 3 hours after inclusion
Secondary outcomes (6)
The frequency of mechanical complications
Mechanical complication include: 1) Bleeding World Health Organization (WHO)-grade 2-4. 2) Pneumothorax visible on post-procedural Xray. 3) Permanent nerve injury. 4) Arrhythmia WHO-grade 3 and 4. 5) Arterial catheterization
Measured: 24 hours after the completion of the central venous catheterization
Needle visibility
Proportion of the insertion-time when the needle is visible on the ultrasound screen
Measured: During the central venous catheterization, up to 4 hours after inclusion
Time to successful vessel puncture
Time to successful vessel puncture
Measured: During the central venous catheterization, up to 4 hours after inclusion
The number of needle redirections
The number of needle redirections during the insertion
Measured: During the central venous catheterization, up to 4 hours after inclusion
The number of failed catheterizations
The number of failed catheterizations in the attempted subclavian vein
Measured: During the central venous catheterization, up to 4 hours after inclusion
Feasibility of the needle guide
Feasibility of the needle guide by means of a questionnaire at the end of the study period.
Measured: Through the study period, anticipated 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start8 Nov 2022
- Primary completion16 Sep 2025
- Study completion30 Sep 2025
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 Complications; Catheter, MechanicalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Kander
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Kander, Region Skane
- Investigators
- Thomas Kander, Assoc. Prof., Principal investigator, Region Skåne and Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513378
- Sponsor's protocol ID
- ELUSIVE
- Acronym
- ELUSIVE
- Status last verified
- Sep 2025
- First submitted
- 21 Aug 2022
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this study, will be made available on reasonable request and after deidentification.
Publications
Naddi L, Borgquist O, Adrian M, Bark BP, Kander T. Ultrasound-guided subclavian vein catheterisation with a needle guide (ELUSIVE): protocol for a randomised controlled study. BMJ Open. 2023 Dec 19;13(12):e080515. doi: 10.1136/bmjopen-2023-080515.
PubMed 38114277
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing In-line Ultrasound Guided Subclavian Vein Catheterization With or Without Needle Guide.
- ClinicalTrials.gov ID
- NCT05513378
- Acronym / sponsor ID
- ELUSIVE / ELUSIVE
- Keywords
- diagnostic imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Thomas KanderUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 24 Aug 2022 (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.
OBJECTIVES The primary objective is to compare if the addition of a needle guide can reduce the number of central venous catheter (CVC) insertions with >1 skin puncture in ultrasound-guided catheterization of the subclavian vein using the long-axis approach with an in-plane needling technique.
Secondary objectives include if this addition 1) decreases the frequency of mechanical complications (defined as bleeding, arterial puncture, arterial catheterization, nerve injury, pneumothorax), 2) increases the time when the needle is visible, 3) decreases the time until successful vessel punction, 4) decreases the number of needle redirections during the insertion, and 5) a comparison between the two groups regarding number of failed catheterizations.
DESIGN This is a prospective, randomised, controlled, parallel intervention study. Patients will be enrolled at Skåne University Hospital in Lund, Sweden. The trial is investigator-initiated and non-commercial.
POPULATION AND INTERVENTION Adults (18 years of age or older) in need of a subclavian CVC for any reason and able to give written informed consent will be included in the study provided no exclusion criteria is fulfilled.
OUTCOMES Primary outcome will be number of CVC insertions with >1 skin puncture. Secondary outcomes include comparison between the two groups regarding 1) the frequency of mechanical complications, 2) proportion of the insertion-time when the needle is visible on the ultrasound (US) screen, 3) time to successful vessel punction, 4) the number of needle redirections during the insertion, 5) number of failed catheterisations, 6) Feasibility of the needle guide evaluated with a questionair to the operators at the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Needle Guide | Experimental | Device: Needle guideA needle guide adapted to a micro-convex ultrasound probe will be used in ultrasound-guided catheterisation of the subclavian vein using the long-axis approach with an in-plane needling technique |
| Without Needle Guide | No intervention | –A micro-convex ultrasound probe without needle guide will be used in ultrasound-guided catheterisation of the subclavian vein using the long-axis approach with an in-plane needling technique |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in need of a central venous catheter .
- Clinical indication for the subclavian route which includes expected time of use >5 days.
- Signed informed consent.
Key exclusion criteria (1 listed)
- Patient is deemed unsuitable for cannulation of the subclavian vein, based on a pre-procedural US examination by the operator, or due to unacceptable patient risk in case of mechanical complication (e.g., severe respiratory failure).
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 |
|---|---|---|
| Needle guideAlso: The Ultra-Pro II™ Needle Guide, model C8-5 PhilipsPlease see the arm/group description | Device | With Needle Guide |
Primary outcome
Number of subclavian catheter insertions with >1 skin puncture
Time frame: During the central venous catheterization, up to 3 hours after inclusion
Number of subclavian catheter insertions with >1 skin puncture
6 secondary outcomes
The frequency of mechanical complications
Time frame: 24 hours after the completion of the central venous catheterization
Needle visibility
Time frame: During the central venous catheterization, up to 4 hours after inclusion
Time to successful vessel puncture
Time frame: During the central venous catheterization, up to 4 hours after inclusion
The number of needle redirections
Time frame: During the central venous catheterization, up to 4 hours after inclusion
The number of failed catheterizations
Time frame: During the central venous catheterization, up to 4 hours after inclusion
Feasibility of the needle guide
Time frame: Through the study period, anticipated 3 years
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 6 Oct 2025.
- Derived from this study: PubMed 38114277Naddi L, Borgquist O, Adrian M, Bark BP, Kander T. Ultrasound-guided subclavian vein catheterisation with a needle guide (ELUSIVE): protocol for a randomised controlled study. BMJ Open. 2023 Dec 19;13(12):e080515. doi: 10.1136/bmjopen-2023-080515.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this study, will be made available on reasonable request and after deidentification.
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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.
Thomas Kander, Assoc. Prof. principal investigator
Region Skåne and Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Needle guide in people with Complications; Catheter, Mechanical and Catheterization, Central Venous, run by Thomas Kander at 1 site in Sweden.
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 3 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: finished, as of the sponsor's last update on 6 Oct 2025. 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 Sweden. 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 subclavian catheter insertions with >1 skin puncture (time frame: During the central venous catheterization, up to 3 hours after inclusion). 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 NCT05513378, 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 6 Oct 2025.