RecruitingACTRN12625001018404

A pilot randomised controlled trial assessing the impact of sharp short bevelled catheters on first-time insertion success

A pilot randomised controlled trial assessing the impact of sharp short bevelled catheters on first-time insertion success in adult patients.


Sponsor

Griffith University

Enrollment

100 participants

Start Date

Nov 11, 2025

Study Type

Interventional

Conditions

Summary

Aims: To determine the feasibility of a larger study in patients with difficult intravenous access to compare short-bevelled peripheral intravenous catheters (SB-PIVCs) with standard PIVCs. Participants: 100 adult patients from medical/surgical and oncology/haematology wards. 3-4 staff PIVC inserters for process evaluation. Methods: Pilot randomised controlled trial. Patients will be randomised to have either a SB-PIVC or standard PIVC inserted to facilitate their clinical care. Patients will be visited daily by research nurses for data collection. The study will end when the PIVC is removed as clinically indicated. Small process evaluation included. Expected outcomes: It will be feasible to conduct a larger trial and first-time insertion success will be higher in the SB-PIVC group than the standard PIVC group.


Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Getting an intravenous (IV) drip inserted can be difficult in some patients — for example, people with hard-to-find veins due to kidney disease, prior IV drug use, or previous failed attempts. Standard IV catheters have a particular needle tip shape, and a newer type called a short-bevel catheter has a different tip design that may be easier to insert successfully on the first try. This pilot study will randomly assign 100 hospital patients who are known to be difficult to cannulate to receive either the new short-bevel catheter or a standard catheter. Researchers will track whether the needle is successfully inserted on the first attempt, and how long the IV line lasts. The study will also help determine whether a larger, definitive trial is worth running. You may be eligible if you are 16 or older, need an IV line for at least 24 hours, and have been identified as someone who is difficult to cannulate — for example, you have no visible veins, a history of difficult access, or a prior failed insertion attempt.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Short bevelled peripheral intravenous catheter (SB-PIVC) (Surflo Zero, 3D-Shin®, Terumo Corporation, Tokyo, Japan) The intervention will be delivered once per patient. The intervention time period (i

Short bevelled peripheral intravenous catheter (SB-PIVC) (Surflo Zero, 3D-Shin®, Terumo Corporation, Tokyo, Japan) The intervention will be delivered once per patient. The intervention time period (ie. device dwell time) will be as clinically indicated. PIVCs will be followed for their entire dwell time. The SB-PIVC will be used at the recruiting hospital and inserted by hospital-credentialled research staff whilst the patient is in hospital and as clinically indicated. The device will be monitored daily for the entirety of it's dwell by research staff to assess for protocol adherence and device complications.


Locations(1)

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12625001018404