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• Withdrawn: Study halted prematurely, prior to enrollment of first participant
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with acute brain injury | Experimental | Subjects requiring placement of a Licox Brain Tissue Oxygen device for their clinical care will also have Near-infrared spectroscopy (NIRS) monitoring system placed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Licox® Brain Tissue Oxygen Monitoring System | Device | Invasive brain tissue oxygenation monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between changes in Licox and NIRS oxygenation measurements | 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. | 3 to 5 days of the monitoring duration |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between changes in pressure reactivity index and Licox versus NIRS | 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). | 3 to 5 days of the monitoring duration |
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro A Rabinstein | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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| Near-infrared spectroscopy (NIRS) | Device | 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 |
|
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |