NCT01448681CompletedNot Applicable
A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension
University of Colorado, Denver1 site in 1 country32 target enrollmentStarted: August 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Algorithm development
Study Overview
Brief Summary
There is statistically significant correlation between invasive measures of intracranial pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow modeling for trend prediction of derived ICP information. Specific aims:
- Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic brain injury in humans.
- Predict and anticipate changes in ICP for preemptive management purposes.
- Analyze characteristics of changes in ICP after treatment failure.
- Analyze data to predict/anticipate confounding physiologic factors that affect ICP and its treatment.
- Test the resulting models in real time.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with severe traumatic brain injury resulting in motor Glasgow Coma Score (GCS) score < 5
- •age 18-89 years
- •health care provider indicating the need for hyperosmolar therapy for elevated ICP
Exclusion Criteria
- •pregnancy
- •incarceration
- •brain death (GCS 3 with fixed, dilated pupils)
- •life-threatening systemic injuries (Abbreviated Injury Scale (AIS) >4 in an organ system other than CNS)
Outcomes
Primary Outcomes
Algorithm development
Time Frame: 24 months
Developing algorithms relating data to intracranial pressure.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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