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OpenTrials
Completed

NCT Number: NCT02404740

Noninvasive Intracranial Pressure and Hydrocephalus Patients

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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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

31 day–35 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 31 days - 35 years
  • Patients seen at Children's Hospital Colorado Neurosurgery clinic, Emergency Department or on an inpatient service
  • 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

  • Pregnant patients
  • Incarcerated patients
  • Patients who object at any time to participating in the study.

Treatment and study plan

Pulse oximetry

Device

Pulse oximetry

Primary outcomes

  1. The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus

    Time frame: baseline

    The algorithm development

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 31, 2015
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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