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

Transonic Systems

Status: Completed

Conditions: Hydrocephalus; Infant, Newborn Diseases; Nervous System Diseases

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01108965

5R44NS049680-03 (U.S. NIH Grant/Contract)

TSI-C-HYDRO-2A-H

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with hydrocephalus
• Instrumented with an Extraventricular drainage system

Exclusion criteria

• Not diagnosed with hydrocephalus
• Not instrumented with an extraventricular drainage system

Trial design

16 participants in 1 patient group

Extraventricular Drainage

Description:

Includes hydrocephalus patients that are in recovery from shunt explanation.