Monitoring blood vessel function and brain blood flow in patients with brain injuries
Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients
This study is testing a new way to monitor blood flow and oxygen levels in the brains of patients with serious brain injuries to help doctors understand their condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 1 site (Louisville, Kentucky) |
| Trial ID | NCT06511804 on ClinicalTrials.gov |
What this trial studies
This observational study utilizes the Mespere LifeSciences NeurOs Cerebral Oximetry system to noninvasively monitor blood vessel functionality in patients with traumatic brain injury, stroke, brain tumors, and brain bleeding. By placing sensors on the patients' foreheads, the study aims to gather data on cerebral oxygen saturation and blood volume, correlating these with intracranial pressure and mean arterial pressure. The goal is to enhance understanding of cerebral hemodynamics and autoregulation in neurocritical care settings.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with a clinical diagnosis of traumatic brain injury, stroke, brain hemorrhage, or brain tumors who are undergoing continuous blood pressure and intracranial pressure monitoring.
Not a fit: Patients without a clinical diagnosis of the specified neurological conditions or those not requiring continuous monitoring may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of brain injuries, potentially enhancing patient outcomes.
How similar studies have performed: While similar noninvasive monitoring approaches have been explored, this specific correlation of blood vessel functionality with cerebral hemodynamics in neurocritical care is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects who meet all the following inclusion criteria may be included: 1. Adults (\> 18 years of age); 2. Able and willing to provide written informed consent for participation by self or legally authorized representatives. 3. 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. 4. 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). 5. 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: 1. Subjects who meet any of the following exclusion criteria will be excluded: 2. Expected to be at increased risk due to study participation (e.g. due to hemodynamic instability), in the medical opinion of an investigator; 3. Pregnant as determined per site standard practice; 4. 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; 5. 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; 6. Allergy to adhesive tape; 7. Ongoing photodynamic therapy.
Where this trial is running
Louisville, Kentucky
- University of Louisville Health — Louisville, Kentucky, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.