Brain Injuries
Conditions
Brief summary
Researchers are trying to assess how accurately and safely NIRS non-invasive monitoring can detect changes in intracranial pressure to determine if this noninvasive device can be used instead of invasive monitoring with Licox in the future.
Interventions
DEVICELicox® Brain Tissue Oxygen Monitoring System
Invasive brain tissue oxygenation monitoring
Non-invasive approach to monitoring brain tissue oxygenation which uses two wavelengths of near infrared light and takes measurements of the ratio of oxyhemoglobin to total hemoglobin
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion: * Subjects with acute brain injury who are age ≥ 18 * Glasgow coma scale score (GCS) ≤ 8 * Neuroimaging concerning for ICP crises, or have active ICP treatment * Have Licox Brain Tissue Oxygen monitor placed as standard of care treatment Exclusion: * CNS infection * Bleeding diathesis or thrombocytopenia \< 50,000 platelets * Subjects with subdural hematomas who have had surgical decompression and bone flap removal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between changes in Licox and NIRS oxygenation measurements | 3 to 5 days of the monitoring duration | Licox measures oxygenation in terms of partial pressure (PtO2) and NIRS measures it in terms of saturation (rSO2). The changes in PtO2 versus the changes in rSO2 will be compared for equivalence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between changes in pressure reactivity index and Licox versus NIRS | 3 to 5 days of the monitoring duration | The pressure reactivity index (PRx) is derived using ICM+ software; the PRx is a correlation coefficient ranging from -1 to +1; PRx \> 0 indicates poor autoregulation. We will investigate if PRx correlates with changes in rSO2 as measured by NIRS (if changes in autoregulation correspond with changes in oxygenation). |
Countries
United States
Outcome results
None listed