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GAVCA 研究:使用移动健康辅助引导技术评估脑室导管放置质量的随机、多中心试验。

GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique.

机构信息

Pediatric Neurosurgery and Department of Neurosurgery, Campus Virchow Klini-kum, Charité Universitätsmedizin Berlin, Berlin, Germany.

Pediatric Neurosurgery and Department of Neurosurgery, Universi-tätsmedizin Göttingen, Göttingen, Germany.

出版信息

Neurosurgery. 2018 Aug 1;83(2):252-262. doi: 10.1093/neuros/nyx420.


DOI:10.1093/neuros/nyx420
PMID:28973670
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6140776/
Abstract

BACKGROUND: Freehand ventricular catheter placement may represent limited accuracy for the surgeon's intent to achieve primary optimal catheter position. OBJECTIVE: To investigate the accuracy of a ventricular catheter guide assisted by a simple mobile health application (mhealth app) in a multicenter, randomized, controlled, simple blinded study (GAVCA study). METHODS: In total, 139 eligible patients were enrolled in 9 centers. Catheter placement was evaluated by 3 different components: number of ventricular cannulation attempts, a grading scale, and the anatomical position of the catheter tip. The primary endpoint was the rate of primary cannulation of grade I catheter position in the ipsilateral ventricle. The secondary endpoints were rate of intraventricular position of the catheter's perforations, early ventricular catheter failure, and complications. RESULTS: The primary endpoint was reached in 70% of the guided group vs 56.5% (freehand group; odds ratio 1.79, 95% confidence interval 0.89-3.61). The primary successful puncture rate was 100% vs 91.3% (P = .012). Catheter perforations were located completely inside the ventricle in 81.4% (guided group) and 65.2% (freehand group; odds ratio 2.34, 95% confidence interval 1.07-5.1). No differences occurred in early ventricular catheter failure, complication rate, duration of surgery, or hospital stay. CONCLUSION: The guided ventricular catheter application proved to be a safe and simple method. The primary endpoint revealed a nonsignificant improvement of optimal catheter placement among the groups. Long-term follow-up is necessary in order to evaluate differences in catheter survival among shunted patients.

摘要

背景:徒手放置心室导管可能无法准确达到术者的初始理想导管位置。

目的:通过多中心、随机、对照、简单盲法研究(GAVCA 研究),研究一款由简易移动医疗应用(mHealth 应用)辅助的心室导管引导装置的准确性。

方法:共有 139 例符合条件的患者在 9 个中心入组。导管放置通过 3 个不同指标进行评估:脑室穿刺次数、分级量表和导管尖端解剖位置。主要终点是同侧心室达到 I 级导管位置的首次置管率。次要终点是导管穿孔的脑室位置、早期心室导管失败和并发症。

结果:在引导组中,主要终点达到 70%,而徒手组为 56.5%(比值比 1.79,95%置信区间 0.89-3.61)。首次穿刺成功率为 100% vs 91.3%(P=.012)。导管穿孔完全位于心室的比例在引导组为 81.4%,而徒手组为 65.2%(比值比 2.34,95%置信区间 1.07-5.1)。早期心室导管失败、并发症发生率、手术持续时间或住院时间在两组间无差异。

结论:引导心室导管应用是一种安全且简便的方法。主要终点显示两组间最佳导管位置的改善无显著差异。需要进行长期随访,以评估分流患者的导管生存率差异。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/849d931609c0/nyx420fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/8c6bff928ee2/nyx420fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/254612fd4b51/nyx420fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/6462ab45b94c/nyx420fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/e95710dacbc9/nyx420fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/849d931609c0/nyx420fig5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/8c6bff928ee2/nyx420fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/254612fd4b51/nyx420fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/6462ab45b94c/nyx420fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/e95710dacbc9/nyx420fig4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84f6/6140776/849d931609c0/nyx420fig5.jpg

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本文引用的文献

[1]
Calvarial slope affecting accuracy of Ghajar Guide technique for ventricular catheter placement.

J Neurosurg. 2016-5

[2]
Image Guidance in Ventricular Cerebrospinal Fluid Shunt Catheter Placement: A Systematic Review and Meta-Analysis.

Neurosurgery. 2015-9

[3]
Pediatric hydrocephalus: systematic literature review and evidence-based guidelines. Part 5: Effect of valve type on cerebrospinal fluid shunt efficacy.

J Neurosurg Pediatr. 2014-11

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Pediatric hydrocephalus: systematic literature review and evidence-based guidelines. Part 3: Endoscopic computer-assisted electromagnetic navigation and ultrasonography as technical adjuvants for shunt placement.

J Neurosurg Pediatr. 2014-11

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Intracranial ventricular catheter placement with a smartphone assisted instrument.

Methods Mol Biol. 2015

[6]
Guiding protractor for accurate freehand placement of ventricular catheter in ventriculoperitoneal shunting.

Acta Neurochir (Wien). 2015-4

[7]
Real-time ultrasound guidance for ventricular catheter placement in pediatric cerebrospinal fluid shunts.

Childs Nerv Syst. 2015-2

[8]
Guided (VENTRI-GUIDE) versus freehand ventriculostomy: study protocol for a randomized controlled trial.

Trials. 2014-12-5

[9]
Factors associated with ventricular catheter movement and inaccurate catheter location: post hoc analysis of the hydrocephalus clinical research network ultrasound-guided shunt placement study.

J Neurosurg Pediatr. 2014-8

[10]
Guided Application of Ventricular Catheters (GAVCA)--multicentre study to compare the ventricular catheter position after use of a catheter guide versus freehand application: study protocol for a randomised trail.

Trials. 2013-12-12

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