Monitoring blood vessel function and brain blood flow in patients with brain injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Louisville Health
  Louisville, Kentucky, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.