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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Elevated ICP (Intracranial Pressure); Intracranial Hypertension

Treatments: Other: No Interventions

Study type: Observational

Funder types: Other

Identifiers

NCT01448681

10-1412

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No 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)

Trial design

32 participants in 1 patient group

SICU patients with ICP

Description:

Surgical intensive care unit patients with elevated intracranial pressure

Treatment:

Other: No Interventions