Impact of softer catheter materials on vein irritation and catheter performance

Effect of Flexible Catheter Materials on Catheter Angle, Dwell Time, Thrombosis and Interstitial Oedema

This study is testing if using softer materials for IV catheters can make them more comfortable and last longer for adults getting treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 26 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Griffith University (other)
• Locations: 1 site (Southport, Queensland)
• Trial ID: NCT06927141 on ClinicalTrials.gov

What this trial studies

This study investigates whether using softer, more flexible materials for peripheral intravenous catheters (PIVCs) can reduce the angle of the catheter tip on the vein surface, potentially minimizing irritation and extending catheter life. The research involves bilateral catheterization in adult participants to assess various outcomes, including the volume of oedema, time until catheter failure, and changes in vein size. By comparing the performance of different catheter materials, the study aims to improve patient comfort and treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-75 who can provide consent and have suitable veins for catheterization.

Not a fit: Patients with a history of bleeding disorders or those currently on anticoagulant medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to longer-lasting intravenous catheters with reduced irritation for patients.

How similar studies have performed: While the approach of using flexible materials is innovative, similar studies have not been widely reported, indicating this may be a novel investigation.

Eligibility criteria

Inclusion Criteria:

* Adult aged 18-75 years.
* Not pregnant at time of recruitment and within 48 hrs of Day 1 procedures (self-reported)
* Normal haematology results as per reference range determined by the laboratory.
* Normal coagulation results as per reference range determined by the laboratory.
* Target cephalic veins readily cannulatable (i.e., \> 2 mm)
* Able and willing to provide verbal and written consent
* Must be an Australian citizen with current Medicare card

Exclusion Criteria:

* History of pro coagulative state / condition (e.g., previous deep vein thrombosis)
* Currently on any anti-coagulant or platelet inhibitor medication. Use of NSAIDs and aspirin will be documented however are not exclusionary.
* Haemophilia or any current or history of bleeding disorder or tendency
* Presence or report of current blood borne disease/infection (e.g., hepatitis, HIV, leukemia, lymphoma)
* History of difficult vascular access
* Allergy or sensitivity to chlorhexidine gluconate, isopropyl alcohol, latex, or skin adhesives
* BMI \< 18.5 kg/m2 or ≥ 35 kg/m2
* Positive results for the urine drug screen at screening or check-in (including opiates, methadone, cocaine, amphetamines)
* History or presence of alcoholism (self-reported) or drug abuse within the past 2 years
* A current or previous medical, physical, mental / cognitive disorder or anatomical conditions that, in the opinion of the chief or sub-investigator, would place the patient at risk, would make them unable to perform study procedures or has the potential to confound interpretation of the study results. (e.g., musculo-skeletal injury, chronic back pain)
* Employed by Terumo, Becton Dickinson, Teleflex Medical, ICUMedical or BBraun (conflict of interest)

Where this trial is running

Southport, Queensland

• Griffith University — Southport, Queensland, Australia (RECRUITING)

Study contacts

• Principal investigator: Principal Investigator — Griffith University
• Study coordinator: Tyson C Charteris, Bachelor of Biomedical Science

Conditions: Healthy, Intravenous Catheterization, Oedema, Thrombosis, Catheter Angle, Interstitial Oedema, Peripheral Intravenous Catheter, Catheter Materials