CompletedNot Applicable

A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension

United States32 participantsStarted 2011-08

Plain-language 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: 1. Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic brain injury in humans. 2. Predict and anticipate changes in ICP for preemptive management purposes. 3. Analyze characteristics of changes in ICP after treatment failure. 4. Analyze data to predict/anticipate confounding physiologic factors that affect ICP and its treatment. 5. Test the resulting models in real time.

Who can participate

Age range18 Years – 89 Years

SexALL

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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)

What they're measuring

Algorithm development

Timeframe: 24 months

Trial details

NCT IDNCT01448681

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-07

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