Noninvasive Intracranial Pressure and Hydrocephalus Patients

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Brief Title

Noninvasive Intracranial Pressure and Hydrocephalus Patients

Official Title

Continuous Noninvasive Estimation of Intracranial Pressure to Assess Ventriculoperitoneal Shunt Malfunction in Patients With Hydrocephalus

Brief Summary

      Using a pulse oximeter, we have developed an algorithm that estimates intracranial pressure
      (ICP) based on patients who have had traumatic brain injuries. Patients with hydrocephalus
      are typically treated with a shunt in order to reduce ICP. At times the shunt can
      malfunction. We believe that our algorithm will help identify when a hydrocephalus patient's
      shunt has malfunctioned.
    

Detailed Description

      A malfunctioning ventriculoperitoneal (VP) shunt will typically cause a rise in intracranial
      pressure, which can be difficult to identify without costly imaging. Novel, state-of-the art
      machine learning techniques can be leveraged to develop an algorithm that noninvasively
      estimates intracranial pressure. The resulting algorithm will accurately determine the
      presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus.
    


Study Type

Observational


Primary Outcome

The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus


Condition

Hydrocephalus

Intervention

Pulse oximetry

Study Arms / Comparison Groups

 VP shunt functioning
Description:  No intervention, just a physiological category--patients with VP shunts that are functioning normally.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

163

Start Date

February 2015

Completion Date

September 2018

Primary Completion Date

September 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Age: 31 days - 35 years

          2. Patients seen at Children's Hospital Colorado Neurosurgery clinic, Emergency
             Department or on an inpatient service

          3. Either hydrocephalus patients with a VP shunt in place (with or without suspicion of
             VP shunt malfunction), or patients with no known intracranial pathology.

        Exclusion Criteria:

          1. Pregnant patients

          2. Incarcerated patients

          3. Patients who object at any time to participating in the study.
      

Gender

All

Ages

31 Days - 35 Years

Accepts Healthy Volunteers

No

Contacts

Steve Moulton, MD, , 



Administrative Informations


NCT ID

NCT02404740

Organization ID

14-1995


Responsible Party

Sponsor

Study Sponsor

University of Colorado, Denver


Study Sponsor

Steve Moulton, MD, Principal Investigator, Childrens Hospital Colorado


Verification Date

October 2019