GAVCA Study: Randomized, Multicenter Trial to Evaluate the Quality of Ventricular Catheter Placement with a Mobile Health Assisted Guidance Technique.
Neurosurgery
; 83(2): 252-262, 2018 08 01.
Article
in En
| MEDLINE
| ID: mdl-28973670
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Cerebrospinal Fluid Shunts
/
Surgery, Computer-Assisted
/
Mobile Applications
Type of study:
Clinical_trials
/
Guideline
Limits:
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Neurosurgery
Year:
2018
Document type:
Article
Affiliation country:
Alemania