Abstract:
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.
Reference:Xu D, Wan S, Yang Z, Jiang Y, Cao C, Liu M, Wang Y, Zhuang Y, Xing H, Mao J, Gu Y, Fang F. Comparison of two blunt dissection sheath insertion techniques in peripherally inserted central catheter placement: a randomized non-inferiority trial. Front Med (Lausanne). 2026 Sep 24;13:1921555. doi: 10.3389/fmed.2026.1921555. PMID: 42851674; PMCID: PMC13646084.