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OpenTrials
Completed

NCT Number: NCT01448681

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

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.

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Key information

Conditions

Intracranial Hypertension Brain Diseases Central Nervous System Diseases Elevated ICP (Intracranial Pressure) Nervous System Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

No interventions

Other

Primary outcomes

  1. Algorithm development

    Time frame: 24 months

    Developing algorithms relating data to intracranial pressure.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Oct 7, 2011
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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