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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Ghent

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Accelerated seldinger technique LPCActive comparator 1 intervention
Group B: Ultra-long peripheral catheterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dwell time

is defined as the duration between the date of catheter insertion and the date of its removal, expressed in hours.

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

Secondary outcomes

1

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

Time frame
Until study completion, an average of 14 days.
2

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.

Time frame
Until study completion, an average of 14 days.
3

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.

Time frame
Until study completion, an average of 14 days.
4

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

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

Other outcomes

Sponsors and contacts

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