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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01448681
Enrollment
32
Registered
2011-10-07
Start date
2011-08-31
Completion date
2019-07-31
Last updated
2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elevated ICP (Intracranial Pressure), Intracranial Hypertension

Keywords

Intracranial Hypertension, Elevated ICP (Intracranial Pressure)

Brief 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.

Interventions

OTHERNo Interventions

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Algorithm development24 monthsDeveloping algorithms relating data to intracranial pressure.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026