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

Intracranial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448681
• Other study ID #: 10-1412
• Status: Completed
• Start date: August 2011
• Est. completion date: July 2019

Study information

• Verified date: September 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Elevated ICP (Intracranial Pressure)
• Hypertension
• Intracranial Hypertension

Intervention

Other:
• No Interventions

Locations

Country	Name	City	State
United States	Denver Health Medical Center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Algorithm development	Developing algorithms relating data to intracranial pressure.	24 months