Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients
Recruiting · NCT06511804 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Louisville
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- Subjects who meet all the following inclusion criteria may be included:
- Adults (\> 18 years of age);
- Able and willing to provide written informed consent for participation by self or legally authorized representatives.
- Clinical diagnosis of traumatic brain injury (TBI), brain hemorrhage, brain tumor, neurotrauma (including closed head injuries, penetrating head injuries, or other forms of neurotrauma), hemorrhage (intracerebral or subarachnoid), or stroke.
- Continuous Blood Pressure Monitoring: Patients must have continuous blood pressure monitoring in place during the study period, obtained from an arterial line. This criterion ensures that we have real-time data on mean arterial pressure (MAP) and systolic pressure (SBP).
- Intracranial Pressure (ICP) Monitoring: Patients must have intracranial pressure (ICP) monitoring in place during the study period. This criterion ensures that we can assess the correlation between our blood vessel functionality parameters (VDC, VR, and VRx) and ICP, a key indicator of intracranial dynamics.
Exclusion criteria
- Subjects who meet any of the following exclusion criteria will be excluded:
- Expected to be at increased risk due to study participation (e.g. due to hemodynamic instability), in the medical opinion of an investigator;
- Pregnant as determined per site standard practice;
- Previously participated in this study, or are enrolled in another research study that could be expected to interfere with participation, in the opinion of the investigator;
- Require or are anticipated to require emergent medical care in which study participation may reasonably delay his/her medical care or increase risk or unfavorable outcome, in the opinion of the investigator;
- Allergy to adhesive tape;
- Ongoing photodynamic therapy.
Where it is running
1 location listed across 1 US state.
- University of Louisville Health - Louisville, Kentucky, United States