Noninvasive Intracranial Pressure and Hydrocephalus Patients

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02404740
• Other study ID #: 14-1995
• Status: Completed
• Start date: February 2015
• Est. completion date: September 2018

Study information

• Verified date: October 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 31 Days to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hydrocephalus

Intervention

Device:
• Pulse oximetry
Pulse oximetry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus	The algorithm development	baseline