GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique
| Autor: | Dhani Schuster, Ulrich-Wilhelm Thomale, Florian Stockhammer, Henrik Giese, Johannes Lemcke, Michael J. Fritsch, Berk Orakcioglu, Martin U. Schuhmann, Peter Vajkoczy, Veit Rohde, Andreas Schaumann, Alexander Sebastian Ahmadi, Leonie Gölz, Hans-Christoph Bock, Elvis J. Hermann, Manolis Polemikos, Stefanie Kästner, Georg Bohner, Thomas Beez |
|---|---|
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Catheters Catheterization law.invention 03 medical and health sciences Standard anatomical position 0302 clinical medicine Randomized controlled trial law Multicenter trial medicine Clinical endpoint Humans Aged business.industry Odds ratio Middle Aged Mobile Applications Cerebrospinal Fluid Shunts Confidence interval Surgery Catheter medicine.anatomical_structure Surgery Computer-Assisted Ventricle 030220 oncology & carcinogenesis Female Neurology (clinical) business Software 030217 neurology & neurosurgery |
| Zdroj: | Neurosurgery. 83:252-262 |
| ISSN: | 1524-4040 0148-396X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|