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

NCT01108965 | Completed

• 2 other identifiers: TSI-C-HYDRO-2A-H5R44NS049680-03
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hydrocephalus; Shunt Dysfunction; Shunt Flow

Outcome Measures

Primary Outcomes (1)

• Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.

  24 hour-period

Secondary Outcomes (1)

• Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.

  24 hour period

Study Arms (1)

Extraventricular Drainage

Includes hydrocephalus patients that are in recovery from shunt explanation.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hydrocephalus patients under the care of SUNY Upstate Medical University

You may qualify if:

• Diagnosed with hydrocephalus
• Instrumented with an Extraventricular drainage system

You may not qualify if:

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

Sponsors & Collaborators

• Transonic Systems Inc.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid samples are to be retained

MeSH Terms

Conditions

Hydrocephalus; Nervous System Diseases; Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Cornelis J Drost

  Transonic Systems Inc.

  PRINCIPAL INVESTIGATOR

• Satish Krishnamurthy, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 22, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

US (1)