Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients

Launched by UNIVERSITY OF LOUISVILLE · Jul 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well certain noninvasive sensors can monitor blood vessel function in patients with serious brain conditions, such as traumatic brain injury, stroke, brain tumors, and brain bleeding. The researchers are particularly interested in understanding how changes in blood vessel behavior relate to important measures of brain health, like intracranial pressure (the pressure inside the skull) and mean arterial pressure (the average blood pressure in a patient’s arteries). By doing this, they hope to learn more about how the brain manages blood flow and responds to injury.

To be eligible for this study, participants must be adults over 18 years old who can give informed consent. They should have a diagnosed brain condition and will need to have monitoring devices in place to continuously check their blood pressure and intracranial pressure during the study. Participants can expect to wear the noninvasive sensors, which are FDA-approved, and contribute to important research that could help improve care for patients with brain injuries. Importantly, individuals who are pregnant, have certain medical risks, or are involved in other conflicting research studies may not be eligible to participate.

Gender

ALL

Eligibility 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.