Comparison of two blunt dissection sheath insertion techniques in peripherally inserted central catheter placement: a randomized non-inferiority trial

OBJECTIVE: To determine whether the one-step sheath insertion technique is non-inferior to the conventional two-step technique with respect to first-attempt sheath insertion success in adults undergoing peripherally inserted central catheter (PICC) placement. METHODS: This prospective, single-center, outcome-assessor-blinded, randomized non-inferiority trial included 500 adult patients undergoing PICC placement, who were randomly assigned 1:1 to the one-step or two-step sheath insertion group. The primary outcome was first-attempt sheath insertion success, with a prespecified non-inferiority margin of -5 percentage points. Secondary outcomes included intraoperative and 24-hour puncture-site bleeding, insertion-site infection, and phlebitis within 7 days. RESULTS: First-attempt sheath insertion was successful in 92.0% (230/250) of patients in the one-step group and 95.6% (239/250) in the two-step group. The absolute risk difference was -3.6 percentage points (95% CI, -7.8 to 0.6), and the lower confidence bound crossed the prespecified non-inferiority margin; therefore, non-inferiority was not demonstrated. Intraoperative puncture-site bleeding was less severe in the one-step group (P < 0.001), although this was a secondary outcome based on semi-quantitative assessment. No significant between-group difference was observed in bleeding at 24 h (P = 0.623). Insertion-site infection occurred in 0.4% of patients in each group, and phlebitis occurred in 1.2% and 0.8% of patients in the one-step and two-step groups, respectively. CONCLUSION: The one-step sheath insertion technique did not demonstrate non-inferiority to the conventional two-step technique for first-attempt sheath insertion success. Although less severe intraoperative puncture-site bleeding was observed with the one-step technique, this secondary finding should be interpreted cautiously. The present findings do not support routine replacement of the two-step technique.