Subcutaneous tunnelling versus conventional insertion of peripherally inserted central catheters in hospitalized patients (TUNNEL-PICC): a multi-centre, open-label, randomized, controlled trial

Abstract

Aim: We aimed to evaluate whether subcutaneous tunnelling in peripherally inserted central catheter (PICC) placement could reduce the occurrence of central-line-associated bloodstream infection (CLABSI). Methods: We conducted an open-label, multi-centre, randomized, controlled trial in five tertiary hospitals. Adult hospitalized patients requiring a PICC were randomized in a one-to-one ratio to conventional (cPICC) or tunnelled PICC (tPICC) arms using a centralized web-based computer-generated stratified randomization. CLABSI rates between groups were compared in a modified intention-to-treat population. Safety including the incidence of exit-site infection or haemorrhage-associated catheter removal were also compared. This trial was registered with Clinical Research Information Service of Republic of Korea (KCT0005521). Findings: From November 2020 to March 2023, 1324 participants were enrolled and randomly assigned to tPICC (N = 662) and cPICC (N = 662). This study was terminated early due to the cohort CLABSI rate being lower than estimated, therefore, the original sample size of 1694 would render the study underpowered to detect a difference in CLABSI rates. In the tPICC, CLABSI occurred in 13 of 651 participants over 11,071 catheter-days (1.2/1000 catheter-days), compared with 20 among 650 patients with cPICC over 11,141 catheter-days (1.8/1000 catheter-days, rate ratio 0.65, 95% confidence interval 0.30–1.38, P=0.30). The incidence of exit-site infection (29 tPICC, 36 cPICC, P=0.5) and haemorrhage-associated catheter removal (11 tPICC, 11 cPICC, P=0.99) did not show a difference between the two groups. Conclusions: Due to insufficient sample size, this study could not demonstrate a statistically significant CLABSI risk reduction in the tPICC group compared with the cPICC group. Both groups had similar rates of exit site infection and bleeding.