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

NCT06927141 | Completed

• 1 other identifier: 2025/150
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy; Intravenous Catheterization; Oedema; Thrombosis

Keywords

Catheter Angle; Interstitial Oedema; Peripheral Intravenous Catheter; Catheter Materials; Indwell; Cannulation; FLEXIT; Vascular Access Device

Outcome Measures

Primary Outcomes (1)

• Catheter Angle

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

  Baseline (Day 1: morning)

Secondary Outcomes (5)

• Volume of interstitial oedema

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

• Time to catheter failure

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

• Thrombus volume in vein

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

• Vein segment volume

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

• Adverse Events

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

Other Outcomes (3)

• Multiple regression analysis

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

• Multiple regression analysis

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

• Multiple regression analysis

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

Study Arms (2)

Left More Flexible Right Less Flexible

EXPERIMENTAL

Participants in this arm will have a more flexible catheter placed in their left arm.

Device: Bilateral Peripheral Intravenous Catheterisation

Left Less Flexible Right More Flexible

EXPERIMENTAL

Participants in this arm will have a less flexible catheter placed in their left arm.

Device: Bilateral Peripheral Intravenous Catheterisation

Interventions

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.

Also known as: Cannulation

Left Less Flexible Right More Flexible; Left More Flexible Right Less Flexible

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of pro coagulative state / condition (e.g., previous deep vein thrombosis)
• 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)

Sponsors & Collaborators

• Griffith University: lead
• Queensland University of Technology: collaborator
• University of Galway: collaborator
• Poitiers University Hospital: collaborator
• Terumo Corporation: collaborator
• Queensland Health: collaborator

Study Sites (1)

Griffith University

Southport, Queensland, 4215, Australia

Location

MeSH Terms

Conditions

Edema; Thrombosis

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Officials

• Principal Investigator

  Griffith University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 15, 2025
• Study Start: May 26, 2025
• Primary Completion: September 8, 2025
• Study Completion: October 9, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning from first participant enrolment with no end date
• Access Criteria: Only team members with direct participant interaction will have access to identifiable data. Other team members (e.g. statistician and computer scientists) will have access to de-identified data which will be limited only to that data which is necessary to complete their assigned role. The funder and general public will have access only to de-identified IPD that underlie results in the form of a published journal article. The funder and all members of the team will have access to the study protocol, SAP, ICF and CSR, but only team members listed on the Protocol have authority to influence/make changes to these documents.

Locations

AU (1)