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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01448681
First received: October 5, 2011
Last updated: May 28, 2013
Last verified: May 2013

October 5, 2011
May 28, 2013
August 2011
December 2013   (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 treatment
No treatment
SICU patients with ICP
Surgical intensive care unit patients with elevated intracranial pressure
Intervention: Other: No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
June 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with severe traumatic brain injury resulting in motor 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 (AIS>4 in an organ system other than CNS)
Both
18 Years to 89 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01448681
10-1412
No
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Steven Moulton, MD University of Colorado, Denver
University of Colorado, Denver
May 2013

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