Noninvasive Intracranial Pressure and Hydrocephalus Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hydrocephalus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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VP shunt functioning

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

Pulse oximetry

Intervention Type DEVICE

Pulse oximetry

VP shunt malfunctioning

No intervention, just a physiological category--patients with VP shunts that are malfunctioning.

Pulse oximetry

Intervention Type DEVICE

Pulse oximetry

No known intracranial pathology

No intervention, just a physiological category--patients without VP shunts that have no known intracranial pathology.

Pulse oximetry

Intervention Type DEVICE

Pulse oximetry

Interventions

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Pulse oximetry

Intervention Type DEVICE

Eligibility Criteria

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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.