Noninvasive Intracranial Pressure and Hydrocephalus Patients

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Hydrocephalus

Treatments: Device: Pulse oximetry

Study type: Observational

Funder types: Other

Identifiers

NCT02404740

14-1995

Details and patient eligibility

About

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.

Full 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.

Enrollment: 163 patients

Sex: All

Ages: 31 days to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

163 participants in 3 patient groups

VP shunt functioning

Description:

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

Treatment:

Device: Pulse oximetry

VP shunt malfunctioning

Description:

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

Treatment:

Device: Pulse oximetry

No known intracranial pathology

Description:

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

Treatment:

Device: Pulse oximetry