Adults, Difficult Intravenous Access
Conditions
Keywords
Long peripheral catheter, Accelerated seldinger technique, Pragmatic randomized controlled trial, Dwell time, complications
Brief 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. 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.
Interventions
DEVICEPowerglide pro™
A long peripheral catheter will be placed under ultrasound guidance. This catheter will be placed by using the Accelerated seldinger technique.
DEVICEIntrocan safety deep access
The catheter will be placed using ultrasound guidance and by using the 'catheter-over-the needle' approach.
Sponsors
University Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dwell time | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Catheter related thrombosis | 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 |
| Number of Participants with Midline catheter related infections | 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. |
| Number of Participants with Phlebitis | 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. |
| Number of Participants with Loss of catheter usability | 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 |
| Number of Participants with Unplanned removal | Until study completion, an average of 14 days. | Removal of an uncomplicated catheter without therapy completion (accidental removal, patient death) |
Countries
Belgium
Outcome results
None listed