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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06927141
Registration number
NCT06927141
Ethics application status
Date submitted
27/03/2025
Date registered
15/04/2025
Date last updated
15/04/2025
Titles & IDs
Public title
Effect of Flexible Catheter Materials on Catheter Angle and Blood Vessel Irritation
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Scientific title
Effect of Flexible Catheter Materials on Catheter Angle, Dwell Time, Thrombosis and Interstitial Oedema
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Secondary ID [1]
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2025/150
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Universal Trial Number (UTN)
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Trial acronym
FLEXIT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Healthy
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Intravenous Catheterization
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Oedema
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Thrombosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Blood
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Bilateral Peripheral Intravenous Catheterisation
Experimental: Left More Flexible Right Less Flexible - Participants in this arm will have a more flexible catheter placed in their left arm.
Experimental: Left Less Flexible Right More Flexible - Participants in this arm will have a less flexible catheter placed in their left arm.
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Catheter Angle
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Assessment method [1]
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Measured against inferior border of vein using vascular ultrasound (in degrees)
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Timepoint [1]
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Baseline (Day 1: morning)
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Secondary outcome [1]
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Volume of interstitial oedema
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Assessment method [1]
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Measured using vascular ultrasound (in mm cubed/microliters)
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Timepoint [1]
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Morning visit (AM) after catheter insertion through to final interventional visit (up to 4 days)
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Secondary outcome [2]
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Time to catheter failure
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Assessment method [2]
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Measured separately for each PIVC (in hours), including differences between catheters and survival analysis.
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Timepoint [2]
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Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
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Secondary outcome [3]
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Thrombus volume in vein
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Assessment method [3]
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Measured using vascular ultrasound (in mm cubed/microliters)
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Timepoint [3]
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Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
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Secondary outcome [4]
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Vein segment volume
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Assessment method [4]
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Measured by vascular ultrasound (in mm cubed/microliters)
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Timepoint [4]
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Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
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Secondary outcome [5]
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Adverse Events
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Assessment method [5]
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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).
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Timepoint [5]
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Morning visit (AM) after catheter insertion through to follow-up visit (up to 7 days)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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)
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/04/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2025
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Actual
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Sample size
Target
26
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Griffith University - Southport
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Recruitment postcode(s) [1]
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4215 - Southport
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Funding & Sponsors
Primary sponsor type
Other
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Name
Griffith University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Queensland University of Technology
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Galway
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Poitiers University Hospital
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Address [3]
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Country [3]
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Other collaborator category [4]
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Commercial sector/industry
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Name [4]
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Terumo Corporation
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Address [4]
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Country [4]
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Other collaborator category [5]
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Government body
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Name [5]
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Queensland Health
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Address [5]
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Country [5]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT06927141
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Principal Investigator
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Address
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Griffith University
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Tyson C Charteris, Bachelor of Biomedical Science
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Address
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Country
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Phone
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+61(0)7 5552 9564
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06927141
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