Effect of Flexible Catheter Materials on Catheter Angle and Blood Vessel Irritation

Summary

Peripheral intravenous catheters (PIVCs; commonly known as "cannulas") are very small tubes made out of rubber-like materials which are inserted into patients' arms using a needle to allow easy access to veins. They are the most commonly-used medical devices in the world, with almost 10 million placed each year in Australia alone. Approximately 40% (almost 4 million) of these devices stop working (i.e. fail) prior to completion of therapy.

The main goal of this study is to learn if softer, more flexible PIVC tip materials reduce the angle of the catheter tip on the vein surface compared to less flexible materials. Reducing the angle of the tip is believed to reduce rubbing on the inner vein surface and causing irritation, extending the life of the catheter. Other goals of this study are to learn if softer materials affect: volume of oedema (i.e. fluid leakage around the vein); time until catheter failure; clot volume in the vein; changes in vein size in response to catheter insertion; adverse event rates (i.e. changes in rates of specific, reportable symptoms); and determining if certain catheters are better for some people than others. This study is recruiting participants of all genders aged 18 - 75 years old who:

* Are not pregnant
* Have a Body Mass Index (BMI) between 18.5 - 35 kg/m2
* Have a current Australian Medicare card
* Do not have a history of chronic/infectious disease or clotting disorders
* Do not have a history of recreational drug use or alcohol abuse within the past 2 years

Participants will:

* Spend two hours in the clinic for screening blood collection, medical questionnaire and ultrasound imaging of veins
* Have one more flexible catheter and one less flexible catheter placed in opposite arms (i.e. participants will have a total of two catheters placed) which will remain in place either (i) until they fail or (ii) for 72 hours, whichever is earlier
* Spend eight hours per day in the clinic on the day the catheters are placed and the two days following for observation and ultrasound imaging
* Spend four hours in the clinic on the third day following placement of the catheters for observation, ultrasound imaging and catheter removal
* Spend one hour in the clinic 24-96 hours after catheter removal for a follow-up assessment and questionnaire

Conditions

• Healthy
• Intravenous Catheterization
• Oedema
• Thrombosis

Interventions

DEVICE

Bilateral Peripheral Intravenous Catheterisation

Participants will have peripheral intravenous catheters inserted. Each participant will receive two different catheters (less flexible = 20 gauge ICUMedical SuperCath5 SP120-20-31T; more flexible = 20 gauge Becton Dickinson Insyte Autoguard Blood Control 381034), with the treatment arm (more flexible) being randomly assigned.

Sponsors & Collaborators

• Queensland University of Technology

  collaborator OTHER

• University of Galway

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• Terumo Corporation

  collaborator INDUSTRY

• Queensland Health

  collaborator OTHER_GOV

• Griffith University

  lead OTHER

Principal Investigators

• Principal Investigator · Griffith University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-26

Primary Completion

2025-09-08

Completion

2025-10-09

Countries

• Australia

Study Locations