Double-Chamber Syringe Versus Classical Syringes For Peripheral Intravenous Drug Administration And Catheter Flushing: A Study Protocol For A Randomised Controlled Trial

Abstract

Background: The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing involves a pre and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, also increasing the need for manipulation of the venous catheter). Methods: A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblinded ward team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blinded research team and registered once a day. Discussion: The study outlined in this protocol will provide valuable insight regarding the effectiveness and safety of this new medical device. The development of a new medical device (dual-chamber syringe, for drug and flush solution) seems to be an important step to facilitate the nurses’ adoption of good clinical practices in intravenous procedures, reducing the catheter manipulations.