None listed
Conditions
Brief summary
The supplier of a new peripheral intravenous catheter (PIVC), BBraun, have engineered a new type of catheter called the ‘Introcan Safety 3’ that contains a new type of stabilisation technology. The investigators would like to test this device against BBraun’s existing device (Introcan Safety) to determine if there is an improvement in devices’ stability and whether this reduces blood clot formation and improves how long the devices work for. We propose to use bilateral cannulation (i.e., cannulate both your left and right lower arms) and allow these PIVCs to stay within your arms for up to 72-hours to determine whether any advantage exists when using the different catheter types. This study will be performed in human participants that meet the study screening criteria. The position and motion of the two catheter types will be monitored using ultrasound, as well as standard observations to document whether the devices are working, whether blood clots, local swelling, redness/pain, and device motion is observed. Participants will also record their experiences with the devices to determine whether using either catheter is associated with improved patient comfort.
Interventions
BRIEF NAME
Participants will have a clinically approved vascular catheter (Introcan Safety 3) inserted into the cephalic vein of either the left or right lower arm under ultrasound guidance for a period of up to 72 hours.
The Introcan Safety 3 device contains a multi-access blood control septum to help prevent blood leakage and exposure during catheter insertion and while connecting/disconnecting Luer devices. This device also has an integrated stabilisation platform, in the design of two wing
BRIEF NAME Participants will have a clinically approved vascular catheter (Introcan Safety 3) inserted into the cephalic vein of either the left or right lower arm under ultrasound guidance for a period of up to 72 hours. The Introcan Safety 3 device contains a multi-access blood control septum to help prevent blood leakage and exposure during catheter insertion and while connecting/disconnecting Luer devices. This device also has an integrated stabilisation platform, in the design of two wings (one wing on each side of the catheter hub) to allow for greater surface area contact with the skin. This greater surface area contact allows for increased anchorage capabilities to the skin surface, therefore increasing the stabilisation of the entire device. The comparator/control device does not have either of these design elements. WHY The purpose of this study is to accurately assess whether catheter micro-motion affects thrombosis and catheter failure in humans, as failure rates of vascular catheters are currently affecting up to 69% of patients in a clinical setting (i.e., hospital). The interventional arm includes the use of a vascular catheter with additional design elements that help to secure and prevent catheter movement as compared to the control arm. WHAT Materials: Participants recruited into the study will be consented using a participant informed consent form (PICF) delivered by the principal- or sub-investigator. Participants will also be provided with home instructions detailing lifestyle, medication, dietary restrictions, catheter care instructions, and safety instructions (including where to go and who to contact in the event of an adverse event of emergent situation). The funding body B. Braun Group (who is providing the vascular catheters used in this study) have provided device use and care training to all members of the study team within 12 weeks of recruitment of the first participant (completed 19/JAN/2023). The study team have also provided a study synopsis and training to all individuals involved. All individuals have completed Good Clinical Practice (GCP) training. Procedure: The vascular catheter location, will be assessed repeatedly over 72 hours using two- and three-dimensional ultrasound, as will assessment of vascular catheter patency and adverse events/failure mechanisms including thrombus formation and phlebitis. At the end of the trial participants will evaluate the benefits and preferences of the two devices tested through the completion of a participant experience survey. WHO: The devices will be inserted by a trained phlebotomist under ultrasound with a minimum of 5 years' experience. The devices will be assessed and imaged using ultrasound by a trained individual of over 2 years' experience. The vascular catheters will be flushed, and the insertion sites assessed, twice daily (AM and PM) by registered nurses. HOW: The interventional device (Introcan Safety 3) will be inserted individually in a face-to-face setting, with insertion of the interventional device taking up to 30 minutes. WHERE: The clinical trial will be undertaken at the Clinical Trials Unit (CTU), Building G40 at the Griffith University Gold Coast campus, Queensland Australia. WHEN and HOW MUCH: The study intervention will be delivered once to each participant, on the first interventional day. At each defined timepoint (up to 14 per participant), the sub-investigator will perform ultrasound assessment and imaging of the vascular catheter distal to the insertion site to image the catheter tip and its motion in the vessel. These images will then be used in data analysis.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
• Female or Male sex • 18-65 years of age • Not pregnant at time of recruitment and within 48 hrs of Day 1 procedures (self-reported) • Normal haemotology results as per reference range determined by our laboratory. • Normal coagulation results as per reference range determined by our laboratory. • Target cephalic veins readily cannulatable (i.e., equal to approximately 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) • Difficult vascular access (i.e., vein must be readily palpable and cannulatable – no less than approximately 2 mm diameter • Allergy or sensitivity to chlorhexidine gluconate, isopropyl alcohol, latex, or skin adhesives • BMI less than 18.5 kg/m^2 or greater than 35 kg/m^2 • 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 Becton Dickinson, Teleflex Medical, ICUMedical or BBraun (conflict of interest)
Outcome results
None listed