Status:
RECRUITING
Correlation Between Noninvasive Blood Vessel Functionality Parameters and Cerebral Hemodynamics in Neurocritical Care Patients
Lead Sponsor:
University of Louisville
Conditions:
Brain Injuries
Intracranial Pressure Increase
Eligibility:
All Genders
18-100 years
Brief Summary
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 c...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 17 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06511804
Start Date
November 17 2024
End Date
June 30 2026
Last Update
May 30 2025
Active Locations (1)
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1
University of Louisville Health
Louisville, Kentucky, United States, 40202