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

Not Applicable

Not yet recruiting

• Conditions: Difficult Intravenous Access; Adults

• Registration Number: NCT07005310
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-14
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-02
• Last Update Submitted: 2025-06-02
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Study Start: 2025-07-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Universitair ziekenhuis Brussel; 🇧🇪 Brussels, Jette, Belgium