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

Objective: We aimed to evaluate whether subcutaneous tunneling in peripherally inserted central catheters (PICC) placement could reduce the occurrence of central-line associated blood stream infection (CLABSI).

Methods: We conducted an open-label, multicentre, 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 tunneled 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 hemorrhage-associated catheter removal were also compared. This trial was registered with Clinical Research Information Service of Republic of Korea (KCT0005521).

Results: From November 2020 to March 2023, 1,324 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 1,694 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 (1.2/1,000 catheter-days), compared with 20 among 650 patients with cPICC over 11,141 catheter-days (1.8/1,000 catheter-days, rate ratio 0.65, 95% CI 0.30-1.38, p=0.30). The incidence of exit-site infection (29 tPICC, 36 cPICC, p=0.5) and hemorrhage-associated catheter removal (11 tPICC, 11 cPICC, p=0.99) was not different between both groups.

Conclusion: Due to insufficient sample size, this study could not demonstrate a statistically significant CLABSI risk reduction in the tPICC group compared to the cPICC group. Both groups had similar rates of exit site infection and bleeding.