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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01448681
First received: October 5, 2011
Last updated: June 7, 2016
Last verified: June 2016

October 5, 2011
June 7, 2016
August 2011
January 2017   (final data collection date for primary outcome measure)
Algorithm development [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Developing algorithms relating data to intracranial pressure.
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Complete list of historical versions of study NCT01448681 on ClinicalTrials.gov Archive Site
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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

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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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Surgical intensive care unit patients
  • Intracranial Hypertension
  • Elevated ICP (Intracranial Pressure)
Other: No Interventions
SICU patients with ICP
Surgical intensive care unit patients with elevated intracranial pressure
Intervention: Other: No Interventions
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
June 2017
January 2017   (final data collection date for primary outcome measure)

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)
Both
18 Years to 89 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01448681
10-1412
No
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University of Colorado, Denver
University of Colorado, Denver
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Principal Investigator: Steven Moulton, MD University of Colorado, Denver
University of Colorado, Denver
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP