Department of Anesthesia, Nayoro City General Hospital, Nishi 7 Minami 8-1, Nayoro, Hokkaido, 096-8511, Japan.
Department of Anesthesiology and Critical Care Medicine, Asahikawa Medical University, Asahikawa, Hokkaido, Japan.
J Med Ultrason (2001). 2021 Oct;48(4):639-644. doi: 10.1007/s10396-021-01118-x. Epub 2021 Jul 28.
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.
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.
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.
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.
尽管与标准超声设备 (SUD) 相比，口袋大小的超声设备 (PUD) 的性能较差，但仍常用于床边使用。我们研究了 PUD 与 SUD 用于超声引导下颈内静脉穿刺的非劣效性。
所有接受全身麻醉和颈内静脉导管放置的择期手术患者均前瞻性纳入本随机非劣效性试验，以比较 PUD 组 (P 组) 和 SUD 组 (S 组) 之间颈内静脉穿刺的质量。主要终点为穿刺时间，次要终点包括穿刺次数、针和导丝可视性以及解剖可视性。
52 名患者被随机分配到两组中的一组 (每组 26 名)。P 组的平均 (SEM) 穿刺时间为 56.4 (10.9) s，S 组为 45.5 (4.0) s。10.9 s 的平均差值在穿刺时间的预设非劣效性边界内 (双侧 95%CI：-12.9-34.6，95%CI 上限：45.5)。P 组的平均 (SEM) 穿刺次数为 1.15 (0.12) 次，S 组为 1.12 (0.06) 次。0.04 次的差值在穿刺次数的预设非劣效性边界内 (双侧 95%CI：-0.24-0.31，95%CI 上限：1.12)。针和导丝可视性和解剖可视性均未显示非劣效性。
与 SUD 相比，PUD 用于颈内静脉穿刺在穿刺时间和穿刺次数方面并不劣于 SUD，尽管在可视性和设备性能方面存在差异。
