Clinical trial NCT06927141: Effect of Flexible Catheter Materials on Catheter Angle and Blood Vessel Irritation
Official title: Effect of Flexible Catheter Materials on Catheter Angle, Dwell Time, Thrombosis and Interstitial Oedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Intravenous Catheterization
Oedema
Thrombosis
Keywords: Catheter Angle
Interstitial Oedema
Peripheral Intravenous Catheter
Catheter Materials
Indwell
Cannulation
FLEXIT
Vascular Access Device
Lead sponsor: Griffith University
Sponsor class: OTHER
Collaborators: name: Queensland University of Technology
name: University of Galway
name: Poitiers University Hospital
name: Terumo Corporation
name: Queensland Health
First posted: 2025-04-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two catheters are being compared simultaneously using a bilateral cannulation model. Participants will be randomised for which catheter will be inserted into either arm, but all participants will be cannulated with both catheters. The randomisation algorithm will be designed to ensure that left- and right-hand dominant participants are distributed evenly across treatment arms.
Primary purpose: PREVENTION

Brief 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


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)

Primary outcomes:
measure: Catheter Angle
timeFrame: Baseline (Day 1: morning)
Secondary outcomes:
measure: Volume of interstitial oedema
timeFrame: Morning visit (AM) after catheter insertion through to final interventional visit (up to 4 days)
measure: Time to catheter failure
timeFrame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
measure: Thrombus volume in vein
timeFrame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
measure: Vein segment volume
timeFrame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
measure: Adverse Events
timeFrame: Morning visit (AM) after catheter insertion through to follow-up visit (up to 7 days)
Other outcomes:
measure: Multiple regression analysis
timeFrame: Screening until follow-up appointment (screening period indeterminate, follow-up appointment completed up to 7 days post-insertion)
measure: Multiple regression analysis
timeFrame: Screening until follow-up appointment (screening period indeterminate, follow-up appointment completed up to 7 days post-insertion)
measure: Multiple regression analysis
timeFrame: Screening until follow-up appointment (screening period indeterminate, follow-up appointment completed up to 7 days post-insertion)
Locations:
city: Southport
country: Australia
facility: Griffith University
state: Queensland
Study officials:
affiliation: Griffith University
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References: