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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

Titles & IDs
Public title
Effect of Flexible Catheter Materials on Catheter Angle and Blood Vessel Irritation
Scientific title
Effect of Flexible Catheter Materials on Catheter Angle, Dwell Time, Thrombosis and Interstitial Oedema
Secondary ID [1] 0 0
2025/150
Universal Trial Number (UTN)
Trial acronym
FLEXIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Intravenous Catheterization 0 0
Oedema 0 0
Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Catheter Angle
Timepoint [1] 0 0
Baseline (Day 1: morning)
Secondary outcome [1] 0 0
Volume of interstitial oedema
Timepoint [1] 0 0
Morning visit (AM) after catheter insertion through to final interventional visit (up to 4 days)
Secondary outcome [2] 0 0
Time to catheter failure
Timepoint [2] 0 0
Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Secondary outcome [3] 0 0
Thrombus volume in vein
Timepoint [3] 0 0
Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Secondary outcome [4] 0 0
Vein segment volume
Timepoint [4] 0 0
Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Secondary outcome [5] 0 0
Adverse Events
Timepoint [5] 0 0
Morning visit (AM) after catheter insertion through to follow-up visit (up to 7 days)

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Griffith University - Southport
Recruitment postcode(s) [1] 0 0
4215 - Southport

Funding & Sponsors
Primary sponsor type
Other
Name
Griffith University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Queensland University of Technology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Galway
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Poitiers University Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Terumo Corporation
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Queensland Health
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Principal Investigator
Address 0 0
Griffith University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tyson C Charteris, Bachelor of Biomedical Science
Address 0 0
Country 0 0
Phone 0 0
+61(0)7 5552 9564
Fax 0 0
Email 0 0
[email protected]
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