Noninvasive Intracranial Pressure and Hydrocephalus Patients

Completed

• Conditions: Hydrocephalus
• Interventions: Device: Pulse oximetry

• Registration Number: NCT02404740
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-26
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-03-31
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-03
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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.

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Exclusion Criteria

1. Pregnant patients
2. Incarcerated patients
3. Patients who object at any time to participating in the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VP shunt malfunctioning	Pulse oximetry	No intervention, just a physiological category--patients with VP shunts that are malfunctioning.
VP shunt functioning	Pulse oximetry	No intervention, just a physiological category--patients with VP shunts that are functioning normally.
No known intracranial pathology	Pulse oximetry	No intervention, just a physiological category--patients without VP shunts that have no known intracranial pathology.

Primary Outcome Measures

Name	Time	Method
The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus	baseline	The algorithm development