Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor

Transonic Systems

Status: Completed

Conditions: Hydrocephalus

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT00652197

TSI-G-HYDRO-1A-H

2R44NS049680-02 (U.S. NIH Grant/Contract)

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 cerebro-spinal 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

Ages: Under 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: newborn through age 20
• Diagnosed with Hydrocephalus
• Instrumented with an Extra-Ventricular Drainage Line

Exclusion criteria

• Age: older than age 20
• Not diagnosed with Hydrocephalus
• Not instrumented with an Extra-Ventricular Drainage Line

Trial design

16 participants in 1 patient group

Extraventricular Drainage

Description:

Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.