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Clinical Trials/NCT01448681
NCT01448681CompletedNot Applicable

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

University of Colorado, Denver1 site in 1 country32 target enrollmentStarted: August 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
32
Locations
1
Primary Endpoint
Algorithm development
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 89 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Algorithm development

Time Frame: 24 months

Developing algorithms relating data to intracranial pressure.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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A Continuous, Non-Invasive, Real-time... | Clinical Trial