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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Powerglide pro™
DeviceA long peripheral catheter will be placed under ultrasound guidance. This catheter will be placed by using the Accelerated seldinger technique.
Introcan safety deep access
DeviceThe catheter will be placed using ultrasound guidance and by using the 'catheter-over-the needle' approach.
Treatment groups
Trial outcomes
Primary outcomes
Dwell time
is defined as the duration between the date of catheter insertion and the date of its removal, expressed in hours.
Secondary outcomes
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
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.
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.
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
Sponsors and contacts
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