A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension
|ClinicalTrials.gov Identifier: NCT01448681|
Recruitment Status : Active, not recruiting
First Posted : October 7, 2011
Last Update Posted : December 14, 2017
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.
|Condition or disease||Intervention/treatment|
|Intracranial Hypertension Elevated ICP (Intracranial Pressure)||Other: No Interventions|
|Study Type :||Observational|
|Actual Enrollment :||32 participants|
|Official Title:||A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||November 2018|
SICU patients with ICP
Surgical intensive care unit patients with elevated intracranial pressure
|Other: No Interventions|
- Algorithm development [ Time Frame: 24 months ]Developing algorithms relating data to intracranial pressure.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448681
|United States, Colorado|
|Denver Health Medical Center|
|Denver, Colorado, United States, 80204|
|Principal Investigator:||Steven Moulton, MD||University of Colorado, Denver|