We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448681
First Posted: October 7, 2011
Last Update Posted: December 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
October 5, 2011
October 7, 2011
December 14, 2017
August 2011
July 2018   (Final data collection date for primary outcome measure)
Algorithm development [ Time Frame: 24 months ]
Developing algorithms relating data to intracranial pressure.
Not Provided
Complete list of historical versions of study NCT01448681 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
32
November 2018
July 2018   (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)
Sexes Eligible for Study: All
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
Not Provided
Not Provided
University of Colorado, Denver
University of Colorado, Denver
Not Provided
Principal Investigator: Steven Moulton, MD University of Colorado, Denver
University of Colorado, Denver
December 2017