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外置脑室引流管隧道长度对小儿患者脑脊液感染率的影响:一项随机、双盲、三臂对照临床试验。

The effect of external ventricular drain tunneling length on CSF infection rate in pediatric patients: a randomized, double-blind, 3-arm controlled trial.

出版信息

J Neurosurg Pediatr. 2021 Mar 19;27(5):525-532. doi: 10.3171/2020.9.PEDS20748. Print 2021 May 1.

DOI:10.3171/2020.9.PEDS20748
PMID:33740757
Abstract

OBJECTIVE

The role of tunneling an external ventricular drain (EVD) more than the standard 5 cm for controlling device-related infections remains controversial.

METHODS

This is a randomized, double-blind, 3-arm controlled trial done in the Children's Medical Center in Tehran, Iran. Pediatric patients (< 18 years old) with temporary hydrocephalus requiring an EVD and no evidence of CSF infection or prior EVD insertion were enrolled. Patients were randomly assigned (1:1:1) into the following arms: 5-cm (standard; group A); 10-cm (group B); or 15-cm (group C) EVD tunnel lengths. The investigators, parents, and person performing the analysis were masked. The surgeon was informed of the length of the EVD by the monitoring board just before operation. Patients were followed until the EVD's fate was established. Infection rate and other complications related to EVDs were assessed.

RESULTS

A total of 105 patients were enrolled in three random groups (group A = 36, group B = 35, and group C = 34). The EVD was removed because there was no further need in most cases (67.6%), followed by conversion to a new EVD or ventriculoperitoneal shunt (15.2%), infection (11.4%), and spontaneous discharge without further CSF diversion requirement (5.7%). No statistical difference was found in infection rate (p = 0.47) or EVD duration (p = 0.81) between the three groups. No group reached the efficacy point sooner than the standard group (group B: hazard ratio 1.21, 95% CI 0.75-1.94, p = 0.429; group C: hazard ratio 1.03, 95% CI 0.64-1.65, p = 0.91).

CONCLUSIONS

EVD tunnel lengths of 5 cm and longer did not show a difference in the infection rate in pediatric patients. Indeed, tunneling lengths of 5 cm and greater seem to be equally effective in preventing EVD infection. Clinical trial registration no.: IRCT20160430027680N2 (IRCT.ir).

摘要

目的

为了控制器械相关感染,对外科引流管(EVD)进行超过标准 5 厘米的隧道式置管,其作用仍存在争议。

方法

这是在伊朗德黑兰儿童医学中心进行的一项随机、双盲、三臂对照试验。本研究纳入了需要临时 EVD 治疗且无脑脊液感染或既往 EVD 置入证据的儿科患者(<18 岁)。将患者随机分为三组(1:1:1):5 厘米(标准组;A 组);10 厘米(B 组);或 15 厘米(C 组)EVD 隧道长度。研究者、患儿父母和分析人员均设盲。手术医生在手术前由监测委员会告知 EVD 长度。患者随访至 EVD 最终处理。评估感染率和与 EVD 相关的其他并发症。

结果

共有 105 例患者被纳入三组随机分组(A 组 36 例,B 组 35 例,C 组 34 例)。大多数情况下,EVD 因不再需要而被移除(67.6%),其次是更换为新的 EVD 或脑室-腹腔分流术(15.2%)、感染(11.4%)和无需进一步脑脊液引流的自发性出院(5.7%)。三组间感染率(p = 0.47)或 EVD 留置时间(p = 0.81)无统计学差异。没有一组比标准组更早达到疗效终点(B 组:危险比 1.21,95%CI 0.75-1.94,p = 0.429;C 组:危险比 1.03,95%CI 0.64-1.65,p = 0.91)。

结论

在儿科患者中,5 厘米及更长的 EVD 隧道长度与感染率无差异。实际上,5 厘米及以上的隧道长度在预防 EVD 感染方面同样有效。临床试验注册号:IRCT20160430027680N2(IRCT.ir)。

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