Skip to content

Noninvasive Intracranial Pressure and Hydrocephalus Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02404740
Enrollment
163
Registered
2015-03-31
Start date
2015-02-28
Completion date
2018-09-30
Last updated
2019-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus

Keywords

VP shunted, Normal intracranial pathology, patients

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.

Interventions

DEVICEPulse oximetry

Pulse oximetry

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
31 Days to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalusbaselineThe algorithm development

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026