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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: December 1, 2016
Last verified: December 2016
  Purpose

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 Interventions

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

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.


Enrollment: 32
Study Start Date: August 2011
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: July 2017 (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 Interventions

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Surgical intensive care unit patients
Criteria

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)
  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 ClinicalTrials.gov identifier: NCT01448681

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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01448681     History of Changes
Other Study ID Numbers: 10-1412 
Study First Received: October 5, 2011
Last Updated: December 1, 2016
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypertension
Intracranial Hypertension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on December 09, 2016