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NCT Number: NCT07005310

Ultra-Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult IV Access Patients

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.

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Key information

Conditions

Difficult Intravenous Access Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair ziekenhuis Brussel

Brussels, Jette, 1090, Belgium

Location contact

Wouter Pieteraerens

CONTACT

[email protected]

024763840

Wouter Pieteraerens

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 access

Device

The catheter will be placed using ultrasound guidance and by using the 'catheter-over-the needle' approach.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Number of Participants with Catheter related thrombosis

    Time frame: Until study completion, an average of 14 days.

    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

  2. Number of Participants with Midline catheter related infections

    Time frame: Until study completion, an average of 14 days.

    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.

  3. Number of Participants with Phlebitis

    Time frame: Until study completion, an average of 14 days.

    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.

  4. Number of Participants with Loss of catheter usability

    Time frame: Until study completion, an average of 14 days.

    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

  5. Number of Participants with Unplanned removal

    Time frame: Until study completion, an average of 14 days.

    Removal of an uncomplicated catheter without therapy completion (accidental removal, patient death)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Ultra Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult Intravenous Access Patients: a Pragmatic Randomised Controlled Trial

Acronym: ULAST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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