Integrated versus nOn-integrated Peripheral inTravenous catheter in adult hospitalised patients. Which Is the most clinical and cost-effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM randomised controlled trial)

Two-arm randomised controlled trial including 2200 adults (18yrs and older) patients. Prospective patients scheduled to have a PIVC inserted and meet the inclusion criteria will be invited to participate. Arm 1: The BD Nexiva closed IV catheter system is an integrated PIVC system. BD Nexiva consists of a number of key components incorporated as one piece: IV catheter, stabilization platform, finger grips, needle safety shield, extension tubing, pinch clamp, Y adapter (double port catheter), and vent plug. The Nexiva catheter is available in a range of sizes from 18 up to 24 gauge and as a single or double port. In this study, the double port will be used; therefore two BD SmartSite connectors will be added to close the Y-connector completely (1100 participants). Arm 2: The traditional non-integrated system is different to the integrated system in that all the components are separated pieces, which need to be attached during cannulation. In this study, the B Braun Introcan Safety 3 or BD Insyte Autoguard catheter will be used. Key components of this catheter are: IV catheter, needle, transparent catheter hub, push-off plate, flashback chamber, removable vented flashplug, safety mechanism (to cover the needle tip). A Connecta extension set 15cm with SmartSite connector/s will be attached to the catheter (1100 participants). Insertion and care of the PIVCs: Study and control catheters will be inserted by trained clinicians at each hospital, who are existing skilled or competent IV inserters. Pre-trial they will have training and simulated practice inserting the study catheter until they feel confident that their skills are at the same level as the control catheter insertion. The training will be provided by a Research Fellow and a Clinical Nurse (both specialists in vascular access devices), and will consist of a single 3-hour workshop with a maximum of six participants. During the training, educative videos with content on the characteristics of the integrated system, insertion techniques, dressing, care, and removal of the device will be shown, followed by a discussion on the main differences between the non-integrated and the integrated systems as well as a Q&A section. After the theoretical content is delivered, clinicians will practice the insertion of the device on insertion arms until they feel equally confident using the integrated catheter (level of confidence >80%). We anticipate 15-20 successful insertions will be sufficient. Patients will have a single PIVC entered into the study. As PIVCs can fail at any time of day and need to be replaced quickly, it is not possible to have subsequent insertions for that patient follow the study protocol. This is because the general hospital staff would not be trained in integrated PIVC insertion. Once patients have a failed PIVC, they will receive the standard institutional PIVC inserted by the hospital staff, and are no longer on the trial. During the trial, patients will have other aspects of PIVC care standardised in all study groups, consistent with usual practice. The devices will remain in situ as per hospital policy. All other PIVC insertion and care practices will be as per individual site policy e.g. skin preparation, dressings, etc,