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

NCT07005310 | Not Yet Recruiting

• 1 other identifier: ONZ-2024-0303
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Difficult Intravenous Access; Adults

Keywords

Long peripheral catheter; Accelerated seldinger technique; Pragmatic randomized controlled trial; Dwell time; complications

Outcome Measures

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.

  Until study completion, an average of 14 days.

Secondary Outcomes (5)

• 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.

Study Arms (2)

Accelerated seldinger technique LPC

ACTIVE COMPARATOR

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).

Device: Powerglide pro™

Ultra-long peripheral catheter

EXPERIMENTAL

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.

Device: Introcan safety deep access

Interventions

Powerglide pro™ DEVICE

A long peripheral catheter will be placed under ultrasound guidance. This catheter will be placed by using the Accelerated seldinger technique.

Accelerated seldinger technique LPC

Introcan safety deep access DEVICE

The catheter will be placed using ultrasound guidance and by using the 'catheter-over-the needle' approach.

Ultra-long peripheral catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Universitair ziekenhuis Brussel

Brussels, Jette, 1090, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 5, 2025
• Study Start: July 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)