University of Louisville Health
Louisville, Kentucky, 40202, United States
Location status: Recruiting
Location contact
Jiapeng Huang, MD, PhD
CONTACT
Jiapeng Huang, Md, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06511804
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.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Louisville, Kentucky, 40202, United States
Location status: Recruiting
Jiapeng Huang, MD, PhD
CONTACT
Jiapeng Huang, Md, PhD
PRINCIPAL_INVESTIGATOR
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 is accessible, free from hair or any underlying wounds beneath the sensor. These sensors are specifically designed to gather crucial data on cerebral oxygen saturation (StO2) and blood volume index (BVI). As per FDA recommendations, should the monitoring extend beyond 6 hours, it is advisable to replace the sensor adhesive to ensure optimal functionality and accuracy. The collected information will be transmitted to the investigators' monitoring system, equipped with preinstalled software that offers real-time insights into several key parameters:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects who meet all the following inclusion criteria may be included:
Exclusion criteria
Mespere sensors will be placed on the temporal areas of the head in patients with invasive intracranial pressure monitoring. Blood pressures, intracranial pressure, and Mespere parameters will be recorded.
Time frame: 1 hour
cerebral hemodynamics and autoregulation as assessed by the noninvasive blood vessel functionality parameters-Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx)-in patients with traumatic brain injury, stroke, brain bleeding
University of Louisville
Other
Acronym: Mespere ICP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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