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

Completed

Conditions studied: Intracranial Hypertension, Elevated ICP (Intracranial Pressure)

In brief

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.

Key facts

Study ID

NCT01448681

Run by

University of Colorado, Denver

People needed

32

Starts

2011-08-01

Expected to finish

2019-07-01

Last updated by the study team

2019-09-30

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Denver Health Medical Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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