GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique. Issue 2 (August 2018)

• Record Type: Journal Article
• Authors: Thomale, Ulrich‐Wilhelm; Schaumann, Andreas; Stockhammer, Florian; Giese, Henrik; Schuster, Dhani; Kästner, Stefanie; Ahmadi, Alexander Sebastian; Polemikos, Manolis; Bock, Hans‐Christoph; Gölz, Leonie; Lemcke, Johannes; Hermann, Elvis; Schuhmann, Martin U; Beez, Thomas; Fritsch, Michael; Orakcioglu, Berk; Vajkoczy, Peter; Rohde, Veit; Bohner, Georg
• Is Part Of: Neurosurgery. Volume 83:Issue 2(2018)
• Publication Date: 2018-08
• Subjects: Hydrocephalus -- Cerebrospinal fluid -- Ventricular catheter guide -- Mobile health -- Shunt failure; Nervous system -- Surgery -- Periodicals; 617.48005
• DOI: 10.1093/neuros/nyx420
• Languages: English
• ISSNs: 0148-396X

Abstract

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.