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The purpose of this clinical research project is to employ Mespere LifeSciences NeurOs Cerebral Oximetry system, equipped with noninvasive sensors approved by the FDA, to monitor and investigate the correlation within a cohort of patients suffering from traumatic brain injury (TBI), stroke, brain tumor, and brain bleeding. This study aims to investigate and establish the correlation between blood vessel functionality parameters-specifically, Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx)-with the crucial physiological indicators, Intracranial Pressure (ICP) and Mean Arterial Pressure (MAP). By doing so, the investigators seek to address fundamental questions surrounding cerebral hemodynamics and autoregulation in various neurological conditions.
For this research, the investigators will strategically position two noninvasive sensors on the patients' foreheads, specifically over the temporal region. It is imperative that the skin in this area is accessible, free from hair or any underlying wounds beneath the sensor. These sensors are specifically designed to gather crucial data on cerebral oxygen saturation (StO2) and blood volume index (BVI). As per FDA recommendations, should the monitoring extend beyond 6 hours, it is advisable to replace the sensor adhesive to ensure optimal functionality and accuracy. The collected information will be transmitted to the investigators' monitoring system, equipped with preinstalled software that offers real-time insights into several key parameters:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial Pressure Noninvasive Monitoring | Device | Mespere sensors will be placed on the temporal areas of the head in patients with invasive intracranial pressure monitoring. Blood pressures, intracranial pressure, and Mespere parameters will be recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| cerebral hemodynamics and autoregulation as assessed by the noninvasive blood vessel functionality parameters-Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx) | cerebral hemodynamics and autoregulation as assessed by the noninvasive blood vessel functionality parameters-Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx)-in patients with traumatic brain injury, stroke, brain bleeding | 1 hour |
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Inclusion Criteria:
Subjects who meet all the following inclusion criteria may be included:
Exclusion Criteria:
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Adult (18 years of age and older) that present for medical care in operating room, intensive care unit (ICU) and/or other departments will be enrolled. Only patients that are safe to conduct the study per medical judgement of the PI will be enrolled in the study. Mespere LifeSciences blood vessel functionality parameters-Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx) will not be used for any medical decisions. This evaluation will be conducted in addition to any other tests, procedures, and/or scans ordered by the participants treating physician. Patients will be required to meet inclusion criteria and meet none of the exclusion criteria.
This population is representative of the general population that is expected to use the device in clinical practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Health | Recruiting | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34899560 | Background | Longhitano Y, Iannuzzi F, Bonatti G, Zanza C, Messina A, Godoy D, Dabrowski W, Xiuyun L, Czosnyka M, Pelosi P, Badenes R, Robba C. Cerebral Autoregulation in Non-Brain Injured Patients: A Systematic Review. Front Neurol. 2021 Nov 16;12:732176. doi: 10.3389/fneur.2021.732176. eCollection 2021. |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D019586 | Intracranial Hypertension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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