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

Completed

• Conditions: Intracranial Hypertension; Elevated ICP (Intracranial Pressure)
• Interventions: Other: No Interventions

• Registration Number: NCT01448681
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-05
• Study First Submitted QC: 2011-10-05
• Study First Posted: 2011-10-07
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SICU patients with ICP	No Interventions	Surgical intensive care unit patients with elevated intracranial pressure

Primary Outcome Measures

Name	Time	Method
Algorithm development	24 months	Developing algorithms relating data to intracranial pressure.

Trial Locations

Locations (1)

Denver Health Medical Center; 🇺🇸 Denver, Colorado, United States