D'Andrea Vito, Prontera Giorgia, Pinna Giovanni, Cota Francesco, Fattore Simona, Costa Simonetta, Migliorato Martina, Barone Giovanni, Pittiruti Mauro, Vento Giovanni
Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy.
Neonatology Unit, Department of Woman and Child Health and Public Health, Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, Rome, Italy.
J Pediatr. 2023 Sep;260:113517. doi: 10.1016/j.jpeds.2023.113517. Epub 2023 May 26.
To evaluate the role of cyanoacrylate glue in reducing dislodgement of umbilical venous catheters (UVCs).
This was a single-center, randomized, controlled, nonblinded trial. All infants requiring an UVC according to our local policy were included in the study. Infants with a UVC with a centrally located tip as verified by real-time ultrasound examination were eligible for the study. Primary outcome was the safety and efficacy of securement by cyanoacrylate glue plus cord-anchored suture (SG group) vs securement by suture alone (S group), as measured by reduction in dislodgment of the external tract of the catheter. Secondary outcomes were tip migration, catheter-related bloodstream infection, and catheter-related thrombosis.
In the first 48 hours after UVC insertion, dislodgement was significantly higher in the S group than in the SG group (23.1% vs 1.5%; P < .001). The overall dislodgement rate was 24.6% in the S group vs 7.7% in the SG group (P = .016). No differences were found in catheter-related bloodstream infection and catheter-related thrombosis. The incidence of tip migration was similar in both groups (S group 12.2% vs SG group 11.7%).
In our single-center study, cyanoacrylate glue was safe and effective for securement of UVCs, and particularly effective in decreasing early catheter dislodgments.
UMIN-CTR Clinical Trial; Registration number: R000045844.
评估氰基丙烯酸酯胶水在减少脐静脉导管(UVC)移位方面的作用。
这是一项单中心、随机、对照、非盲试验。根据我们当地政策需要放置UVC的所有婴儿均纳入研究。经实时超声检查证实导管尖端位于中心位置的UVC婴儿符合研究条件。主要结局是通过氰基丙烯酸酯胶水加脐带锚定缝线固定(SG组)与仅通过缝线固定(S组)的安全性和有效性,通过导管外部通道移位的减少来衡量。次要结局是尖端移位、导管相关血流感染和导管相关血栓形成。
在插入UVC后的头48小时内,S组的移位率显著高于SG组(23.1%对1.5%;P<0.001)。S组的总体移位率为24.6%,而SG组为7.7%(P=0.016)。在导管相关血流感染和导管相关血栓形成方面未发现差异。两组的尖端移位发生率相似(S组12.2%对SG组11.7%)。
在我们的单中心研究中,氰基丙烯酸酯胶水用于固定UVC是安全有效的,尤其在减少早期导管移位方面有效。
UMIN-CTR临床试验;注册号:R000045844。