Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a study protocol for a randomized controlled trial

Abstract

BACKGROUND: Peripherally inserted central catheters (PICCs) are now widely used in modern medicine, and associated complications have also increased. Central line-associated bloodstream infection (CLABSI) is the most serious complication because it can cause extended hospital stays and increase costs. Furthermore, it can contribute to dire consequences for critically ill patients. Subcutaneous tunnelling for central venous catheters is an accepted method to reduce the risk of CLABSI. However, it is not generally adopted for PICC placement in most hospitals because its safety and efficacy have not been thoroughly evaluated. METHODS: In this multi-institutional, prospective, non-blinded pragmatic randomized controlled trial, 1694 patients treated at five referral hospitals will be assigned to one of two parallel arms (conventional and tunnelled PICC groups) using computer-generated stratified randomization. The conventional group will undergo PICC placement by routine practice. In the tunnelled PICC (tPICC) group, additional subcutaneous tunnelling will be applied. Patients will be followed until PICC removal or the end of this study. The primary endpoint is whether subcutaneous tunnelling reduced the rate of CLABSI compared to the conventional method. The secondary endpoints are technical success rates, complications including exit-site bleeding or infection, and the procedure time between the groups. DISCUSSION: Subcutaneous tunnelling is a widely used method to reduce catheter-associated infection. However, it has not been thoroughly applied for PICC. A randomized trial is needed to objectively assess the effects of the subcutaneous tunnel in PICC placement. This TUNNEL-PICC trial will provide evidence for the effectiveness of subcutaneous tunnelling in decreasing the risk of CLABSI. TRIAL REGISTRATION: Clinical Research Information Service (CRiS) KCT0005521.