NCT01108965

Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.

A Flow Monitor for Pediatric Hydrocephalic Shunts

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Transonic Systems Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts. The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag. After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line. This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.

Conditions

• Hydrocephalus
• Nervous System Diseases
• Infant, Newborn Diseases

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2010-04-22
• Last updated: 2016-05-27

Locations

1 site across 1 country: United States