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Completed

NCT Number: NCT06927141

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

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

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Key information

Conditions

Healthy Cardiovascular Diseases Edema Embolism and Thrombosis Intravenous Catheterization Oedema Pathological Conditions, Signs and Symptoms Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Griffith University

Southport, Queensland, 4215, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Bilateral Peripheral Intravenous Catheterisation

Device

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.

Other names: Cannulation

Primary outcomes

  1. Catheter Angle

    Time frame: Baseline (Day 1: morning)

    Measured against inferior border of vein using vascular ultrasound (in degrees)

Secondary outcomes

  1. Volume of interstitial oedema

    Time frame: Morning visit (AM) after catheter insertion through to final interventional visit (up to 4 days)

    Measured using vascular ultrasound (in mm cubed/microliters)

  2. Time to catheter failure

    Time frame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)

    Measured separately for each PIVC (in hours), including differences between catheters and survival analysis.

  3. Thrombus volume in vein

    Time frame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)

    Measured using vascular ultrasound (in mm cubed/microliters)

  4. Vein segment volume

    Time frame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)

    Measured by vascular ultrasound (in mm cubed/microliters)

  5. Adverse Events

    Time frame: Morning visit (AM) after catheter insertion through to follow-up visit (up to 7 days)

    Identified by study team and/or nurses and reviewed by a medical practitioner (identified individually and aggregate of all adverse events; expressed as a count and percentage of catheters inserted).

Other outcomes

  1. Multiple regression analysis

    Time frame: Screening until follow-up appointment (screening period indeterminate, follow-up appointment completed up to 7 days post-insertion)

    Determining independent predictors from demographic data (i.e. biological sex (M/F)) on outcome measures (catheter dwell/failure time, thrombus/vessel/oedema measrements, adverse events).

  2. Multiple regression analysis

    Time frame: Screening until follow-up appointment (screening period indeterminate, follow-up appointment completed up to 7 days post-insertion)

    Determining independent predictors from demographic data (i.e. age (years)) on outcome measures (catheter dwell/failure time, thrombus/vessel/oedema measrements, adverse events).

  3. Multiple regression analysis

    Time frame: Screening until follow-up appointment (screening period indeterminate, follow-up appointment completed up to 7 days post-insertion)

    Determining independent predictors from demographic (i.e. biological sex (M/F), age (years), height (cm), weight and height will be combined to report BMI in kg/m^2), family history of disease etc), haematologic (i.e. platelet, white/red blood cell counts [cells per microliter], clotting times [PT/APTT; sec], fibrinogen [mg/dL or g/L], DDimer [mg/L or ug/mL] etc and biochemical tests [liver [U/L] and kidney function tests mg/dL or umol/L], protein/s, petdides [ug/L or ng/mg protein], lipid profile (mmol/L), glucose (mg/dL or mmol/L) etc) on outcome measures (catheter dwell/failure time, thrombus/vessel/oedema measrements, adverse events).

Sponsors and collaborators

Lead sponsor

Griffith University

Other

Collaborators

  • Poitiers University Hospital
  • Queensland Health
  • Queensland University of Technology
  • Terumo Corporation
  • University of Galway

Registry information

Official study title

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

Acronym: FLEXIT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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