A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension (NCT01448681) | Clinical Trial Compass
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 range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.