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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
27
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.
Griffith University
Southport, Queensland, Australia
Catheter Angle
Measured against inferior border of vein using vascular ultrasound (in degrees)
Time frame: Baseline (Day 1: morning)
Volume of interstitial oedema
Measured using vascular ultrasound (in mm cubed/microliters)
Time frame: Morning visit (AM) after catheter insertion through to final interventional visit (up to 4 days)
Time to catheter failure
Measured separately for each PIVC (in hours), including differences between catheters and survival analysis.
Time frame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Thrombus volume in vein
Measured using vascular ultrasound (in mm cubed/microliters)
Time frame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Vein segment volume
Measured by vascular ultrasound (in mm cubed/microliters)
Time frame: Morning visit (AM) after catheter insertion through to catheter removal and/or 72 hours post-insertion (whichever is earlier)
Adverse Events
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).
Time frame: Morning visit (AM) after catheter insertion through to follow-up visit (up to 7 days)
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