Noninvasive Intracranial Pressure and Hydrocephalus Patients
Continuous Noninvasive Estimation of Intracranial Pressure to Assess Ventriculoperitoneal Shunt Malfunction in Patients With Hydrocephalus
1 other identifier
observational
163
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedOctober 4, 2019
October 1, 2019
3.6 years
March 26, 2015
October 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The presence or absence of ventriculoperitoneal shunt malfunction in patients with hydrocephalus
The algorithm development
baseline
Study Arms (3)
VP shunt functioning
No intervention, just a physiological category--patients with VP shunts that are functioning normally.
VP shunt malfunctioning
No intervention, just a physiological category--patients with VP shunts that are malfunctioning.
No known intracranial pathology
No intervention, just a physiological category--patients without VP shunts that have no known intracranial pathology.
Interventions
Pulse oximetry
Eligibility Criteria
VP shunted patient, Normal intracranial pathology patient
You may qualify if:
- 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.
You may not qualify if:
- Pregnant patients
- Incarcerated patients
- Patients who object at any time to participating in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steve Moulton, MD
Childrens Hospital Colorado
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2015
First Posted
March 31, 2015
Study Start
February 1, 2015
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
October 4, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share