Difficult Intravenous AccessULASTNCT07005310
Ultra-Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult IV Access Patients
A study testing Powerglide pro™ and Introcan safety deep access in people with Difficult Intravenous Access and Adults, run by University Ghent at 1 site in Belgium.
Trial summary
The aim of this study is to perform a comparative analysis of clinical outcomes associated with the use of an ultra-long peripheral catheter using (catheter-over-the-needle technique) versus an AST-long peripheral catheter in adult patients with difficult intravenous access (DIVA) in a real-world clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Intravenous Access, Adults
- What is being tested?
- Powerglide pro™ and Introcan safety deep access
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 inpatients with DIVA, requiring placement of a long peripheral catheter, will be included in the study.
- A digital request form for venous access must be completed by the treating physician at the ward.
- Patients must be proficient in either Dutch or French
- Patients must have decision-making capacity or be represented by a legal representative.
Who cannot join
- Expected therapy duration of less than 24 hours
- pregnancy
- Need for central venous access
- Inability to locate a deep peripheral vein in the upper extremity prior enrollment in the study
- Veins located deeper than 1.6cm prior enrollment in the study
- withdrawal of consent, or presentation at a time when study personnel are unavailable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Universitair ziekenhuis Brussel
Brussels, Jette, 1090
Wouter Pieteraerens, 024763840, wouter.pieteraerens@uzbrussel.be
Wouter Pieteraerens
About this study
Official title: Ultra Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult Intravenous Access Patients: a Pragmatic Randomised Controlled Trial
The aim of this study is to perform a comparative analysis of clinical outcomes associated with the use of an ultra-long peripheral catheter using (catheter-over-the-needle technique) versus an AST-long peripheral catheter in adult patients with difficult intravenous access (DIVA) in a real-world clinical setting. Specifically, the study will assess potential benefits, including longer mean catheter dwell time and improved catheter usability, as well as potential harms, such as increased incidence of catheter-related thrombosis, infections, phlebitis, infiltration, and unplanned catheter removal.
- Conditions
- Difficult Intravenous Access, Adults
- Being tested
- Powerglide pro™, Introcan safety deep access
- Keywords
- Long peripheral catheter, Accelerated seldinger technique, Pragmatic randomized controlled trial, Dwell time, complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powerglide pro™Device
A long peripheral catheter will be placed under ultrasound guidance. This catheter will be placed by using the Accelerated seldinger technique.
Introcan safety deep accessDevice
The catheter will be placed using ultrasound guidance and by using the 'catheter-over-the needle' approach.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated seldinger technique LPC | Active comparator | One study arm will be assigned the AST-long peripheral catheter (Powerglide Pro long peripheral catheter, BD) available in 18G 100 mm, 20G 100 mm (approx. 3.94 inches) and 22G 80 mm (approx. 3.15 inches). Receives: Device: Powerglide pro™ |
| Ultra-long peripheral catheter | Experimental | The other study arm will be assigned the ultralong peripheral catheter (Introcan Safety deep access catheter, B. Braun) available in 18, 20 and 22G and 63.5 mm (approx. 2.5 inches) in length. Receives: Device: Introcan safety deep access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dwell time
is defined as the duration between the date of catheter insertion and the date of its removal, expressed in hours.
Measured: Until study completion, an average of 14 days.
Secondary outcomes (5)
Number of Participants with Catheter related thrombosis
CRT indicates the presence of clots in the vascular system after the placement of a catheter due to induced trauma to the endothelium, inflammation, individual patient factors and catheter related factors. The following types of thrombi will be reported.
- Mural thrombus or Obstructive thrombus
- Symptomatic or asymptomatic thrombus
Measured: Until study completion, an average of 14 days.
Number of Participants with Midline catheter related infections
MLABSI are defined as laboratory confirmed bloodstream infections in patients who had a midline catheter in place for two or more calendar days prior to confirmation. MLABSI will be diagnosed as:
- differential time to positivity >2 h in comparing cultures blood samples drawn from the catheter and from a peripheral vein if the catheter is fully patent
- isolation of the same microorganism (species and antimicrobial susceptibility testing) from the catheter tip (>15 colony forming units) and a peripheral blood sample if blood draws are impossible
These parameters will be combined to report MLABSI.
Measured: Until study completion, an average of 14 days.
Number of Participants with Phlebitis
Phlebitis will be defined as the inflammation of a vein resulting from mechanical, chemical, or bacterial causes. The severity of this inflammation will be assessed using the Visual Infusion Phlebitis (VIP) scale, which assigns a score ranging from 0 to 5, with 0 indicating a healthy insertion site. A score of 5 on the VIP scale signifies severe pain, redness, palpable venous cord, and fever-related complaints. A score of 2, indicating pain, erythema and swelling, necessitates immediate catheter relocation. Symptomatic catheter-related thrombosis must be excluded in advance.
Measured: Until study completion, an average of 14 days.
Number of Participants with Loss of catheter usability
Loss of catheter usability will be registered by using the following categories38:
Total occlusion: inability to infuse and aspirate Sub-occlusion: Difficulty in infusing and aspirating Persistent withdrawal occlusion: No blood withdrawal possibility
Measured: Until study completion, an average of 14 days.
Number of Participants with Unplanned removal
Removal of an uncomplicated catheter without therapy completion (accidental removal, patient death)
Measured: Until study completion, an average of 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
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 Difficult Intravenous AccessStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Torsy, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005310
- Sponsor's protocol ID
- ONZ-2024-0303
- Acronym
- ULAST
- Status last verified
- Jun 2025
- First submitted
- 14 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is confidential.
Publications
Pieteraerens W, Vanhonacker D, Beeckman K, Torsy T. Ultra long peripheral catheter versus accelerated Seldinger technique long peripheral catheter in difficult intravenous access patients (ULAST): a pragmatic randomised controlled trial protocol. BMJ Open. 2026 Feb 6;16(2):e106079. doi: 10.1136/bmjopen-2025-106079.
PubMed 41651529
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult Intravenous Access Patients: a Pragmatic Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07005310
- Acronym / sponsor ID
- ULAST / ONZ-2024-0303
- Conditions
- Difficult Intravenous Access, Adults
- Keywords
- Long peripheral catheter, Accelerated seldinger technique, Pragmatic randomized controlled trial, Dwell time, complications
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 5 Jun 2025 (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 aim of this study is to perform a comparative analysis of clinical outcomes associated with the use of an ultra-long peripheral catheter using (catheter-over-the-needle technique) versus an AST-long peripheral catheter in adult patients with difficult intravenous access (DIVA) in a real-world clinical setting. Specifically, the study will assess potential benefits, including longer mean catheter dwell time and improved catheter usability, as well as potential harms, such as increased incidence of catheter-related thrombosis, infections, phlebitis, infiltration, and unplanned catheter removal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated seldinger technique LPC | Active comparator | Device: Powerglide pro™One study arm will be assigned the AST-long peripheral catheter (Powerglide Pro long peripheral catheter, BD) available in 18G 100 mm, 20G 100 mm (approx. 3.94 inches) and 22G 80 mm (approx. 3.15 inches). |
| Ultra-long peripheral catheter | Experimental | Device: Introcan safety deep accessThe other study arm will be assigned the ultralong peripheral catheter (Introcan Safety deep access catheter, B. Braun) available in 18, 20 and 22G and 63.5 mm (approx. 2.5 inches) in length. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult inpatients with DIVA, requiring placement of a long peripheral catheter, will be included in the study.
- A digital request form for venous access must be completed by the treating physician at the ward.
- Patients must be proficient in either Dutch or French
- Patients must have decision-making capacity or be represented by a legal representative.
Key exclusion criteria (6 listed)
- Expected therapy duration of less than 24 hours
- pregnancy
- Need for central venous access
- Inability to locate a deep peripheral vein in the upper extremity prior enrollment in the study
- Veins located deeper than 1.6cm prior enrollment in the study
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 |
|---|---|---|
| Powerglide pro™A long peripheral catheter will be placed under ultrasound guidance. This catheter will be placed by using the Accelerated seldinger technique. | Device | Accelerated seldinger technique LPC |
| Introcan safety deep accessThe catheter will be placed using ultrasound guidance and by using the 'catheter-over-the needle' approach. | Device | Ultra-long peripheral catheter |
Primary outcome
Dwell time
Time frame: Until study completion, an average of 14 days.
is defined as the duration between the date of catheter insertion and the date of its removal, expressed in hours.
5 secondary outcomes
Number of Participants with Catheter related thrombosis
Time frame: Until study completion, an average of 14 days.
Number of Participants with Midline catheter related infections
Time frame: Until study completion, an average of 14 days.
Number of Participants with Phlebitis
Time frame: Until study completion, an average of 14 days.
Number of Participants with Loss of catheter usability
Time frame: Until study completion, an average of 14 days.
Number of Participants with Unplanned removal
Time frame: Until study completion, an average of 14 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 41651529Pieteraerens W, Vanhonacker D, Beeckman K, Torsy T. Ultra long peripheral catheter versus accelerated Seldinger technique long peripheral catheter in difficult intravenous access patients (ULAST): a pragmatic randomised controlled trial protocol. BMJ Open. 2026 Feb 6;16(2):e106079. doi: 10.1136/bmjopen-2025-106079.
- Individual participant dataSharing planned: No. The data is confidential.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powerglide pro™ and Introcan safety deep access in people with Difficult Intravenous Access and Adults, run by University Ghent at 1 site in Belgium.
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 4 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: opening soon, as of the sponsor's last update on 5 Jun 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dwell time (time frame: Until study completion, an average of 14 days.). 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 NCT07005310, 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 Jun 2025.