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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|