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A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension | Clinical Trials | Clareo Health

COMPLETED

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

NCT01448681•University of Colorado, Denver

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

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)

Locations (1)

Denver Health Medical Center

Denver, Colorado, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

July 1, 2019

Completion Date

July 1, 2019

Last Updated

September 30, 2019

Enrollment

ACTUAL participants

Conditions

Intracranial HypertensionElevated ICP (Intracranial Pressure)

Interventions

No Interventions

OTHER

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IIH - Idiopathic Intracranial Hypertension

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

IIH Intervention: A Clinical Trial Comparing 2 Treatments (Shunts and Stents) Evaluation Of Clinical Effectiveness And Cost Effectiveness

Lidocaine, Dexmedetomidine, Esmolol and Magnesium Effect on Optic Nerve Sheath Diameter After Laryngoscopy

Venous Sinus Stenting With the River Stent in IIH

Tirzepatide in Idiopathic Intracranial Hypertension Trial

Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury

Augmented Reality-Assisted Neurosurgical Drain Placement