Ultra Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult Intravenous Access Patients: a Pragmatic Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University Ghent
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Dwell time
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Accelerated seldinger technique LPC
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).
Intervention: Powerglide pro™ (Device)
Ultra-long peripheral catheter
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.
Intervention: Introcan safety deep access (Device)
Outcomes
Primary Outcomes
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
- Number of Participants with Catheter related thrombosis(Until study completion, an average of 14 days.)
- Number of Participants with Midline catheter related infections(Until study completion, an average of 14 days.)
- Number of Participants with Phlebitis(Until study completion, an average of 14 days.)
- Number of Participants with Loss of catheter usability(Until study completion, an average of 14 days.)
- Number of Participants with Unplanned removal(Until study completion, an average of 14 days.)
Investigators
Tim Torsy
Prof. Dr.
University Ghent