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

NCT ID: NCT01448681

Last Updated: 2019-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Hypertension Elevated ICP (Intracranial Pressure)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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SICU patients with ICP

Surgical intensive care unit patients with elevated intracranial pressure

No Interventions

Intervention Type OTHER

Interventions

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No Interventions

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Moulton, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Denver Health Medical Center

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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10-1412

Identifier Type: -

Identifier Source: org_study_id

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