Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: October 5, 2011
Last updated: December 1, 2014
Last verified: December 2014

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.

Condition Intervention
Intracranial Hypertension
Elevated ICP (Intracranial Pressure)
Other: No treatment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Algorithm development [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Developing algorithms relating data to intracranial pressure.

Estimated Enrollment: 75
Study Start Date: August 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
SICU patients with ICP
Surgical intensive care unit patients with elevated intracranial pressure
Other: No treatment
No treatment


Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Surgical intensive care unit patients


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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01448681

United States, Colorado
Denver Health Medical Center
Denver, Colorado, United States, 80204
Sponsors and Collaborators
University of Colorado, Denver
Principal Investigator: Steven Moulton, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver Identifier: NCT01448681     History of Changes
Other Study ID Numbers: 10-1412
Study First Received: October 5, 2011
Last Updated: December 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Intracranial Hypertension
Elevated ICP (Intracranial Pressure)

Additional relevant MeSH terms:
Intracranial Hypertension
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases processed this record on March 03, 2015