A Non-Inferiority Randomized Clinical Trial Investigating Efficacy and Safety of an Innovative Medical Device in the Reduction of Mechanical Complications of Peripheral Intravenous Catheters

It is estimated that around 1.5 billion PIVC are sold yearly throughout the globe, and placing them is one of the most common invasive procedures in hospitalised patients, with up to 90% receiving one, yet there is a failure rate of up to 69%.1-5 Some of the most common causes of failure are considered to be phlebitis, subcutaneous infiltration, occlusion and dislodgement. These failure rates vary widely throughout the globe, where published data suggests rates of 8-44% for phlebitis, 5-21% for infiltration, 7.6-16% for occlusion and 5-10% for dislodgement.4,6-12 Phlebitis, commonly defined as an inflammatory process in the wall of a vein, resulting in a blood clot formation; while infiltration is defined as the inadvertent leakage of a solution into the surrounding tissue; occlusion is defined as catheter failure due to blockage, and dislodgement the accidental/ in adverted removal of the PIVC before intended.13 Previous studies have suggested that mechanical irritation could be an important factor resulting in PIVC failure.14-16 In the case of phlebitis, mechanical movements against the endothelial wall could initiate a cascade of prothrombotic events resulting in the formation of a blood clot, something that has been demonstrated in a simulated environment.14,17,18 Furthermore micromechanical movements of the PIVC could eventually lead the PIVC to migrate from within the vessel wall to be unintentionally placed outside the vessel, yet, still in the surrounding tissue causing infiltration. Occlusion is the sudden block of the PIVC, where flushing or aspirating from the PIVC is not possible. Dislodgement of a PIVC is the act of mechanical movement of the PIVC from the intravascular space to the surrounding environment outside of the body.

Therefore, there is a need to investigate potential new methods for prevention of these mechanical complications, and one method could be in the reduction of mechanical forces acting on the vessels. The aim of this study is to investigate the safety and effectiveness of a new medical device in reducing the number of mechanical complications during IV therapy.

To answer this aim, a non-inferiority randomized clinical trial will be executed at two sites, where patients having a vascular access will be examined in a systematic fashion. Inclusion criteria are: having VAD, >18 years of age, speak local language, absence of signs of phlebitis or infiltration, and a signed consent form. Exclusion criteria are: VAD for sampling only, pregnancy, unable to obtain informed consent, patients under palliative care and VAD for bolus infusion only.

A total of 548 patients will be recruited to this study, and it is estimated to take 5 months to complete. The primary outcomes/endpoints are to investigate the rate of mechanical complications in the form of phlebitis, infiltration, occlusion and dislodgement. While secondary outcomes/endpoints will be identifying the frequency and severity of any adverse events, healthcare opinions on the device and the economic burden of the mechanical complications. No follow up is planned in this trial.