Purpose: Pocket-sized ultrasound devices (PUDs) are commonly adopted for bedside use despite their inferior performance compared with standard ultrasound devices (SUDs). We investigated the non-inferiority of PUDs versus SUDs for ultrasound-guided internal jugular venipuncture.
Methods: All patients undergoing scheduled surgery with general anesthesia and internal jugular vein catheter placement were prospectively included in this randomized non-inferiority trial to compare the qualities of the internal jugular venipuncture between the PUD group (Group P) and SUD group (Group S). The primary endpoint was puncture time, and the secondary endpoints included number of punctures, needle and guidewire visibility, and anatomic visibility.
Results: Fifty-two patients were randomized to one of the two groups (26 per group). The mean (SEM) puncture time was 56.4 (10.9) s in Group P and 45.5 (4.0) s in Group S. The mean difference of 10.9 s was within the prespecified non-inferiority margin of 100% (two-sided 95% CI: - 12.9-34.6, upper limit of the 95% CI: 45.5) for puncture time. The mean (SEM) number of punctures was 1.15 (0.12) times in Group P and 1.12 (0.06) times in Group S. The difference of 0.04 punctures was within the prespecified non-inferiority margin of 100% (two-sided 95% CI: - 0.24-0.31, upper limit of the 95% CI: 1.12) for number of punctures. Non-inferiority was not shown for needle and guidewire visibility and anatomic visibility.
Conclusion: PUDs for internal jugular venipuncture are not inferior to SUDs with regard to puncture time and number of punctures, despite differences in visibility and device performance.
Keywords: Central venipuncture; Internal jugular vein; Non-inferiority trial; Pocket-sized ultrasound device; Ultrasound-guided central venous catheter placement.
© 2021. The Japan Society of Ultrasonics in Medicine.