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

NCT06511804 | Recruiting FDA Device

• 1 other identifier: 24.0331
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Brain Injuries; Intracranial Pressure Increase; Monitoring

Keywords

intracranial pressure; monitoring; noninvasive

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  1 hour

Interventions

Intracranial Pressure Noninvasive Monitoring DEVICE

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (18 years of age and older) that present for medical care in operating room, intensive care unit (ICU) and/or other departments will be enrolled. Only patients that are safe to conduct the study per medical judgement of the PI will be enrolled in the study. Mespere LifeSciences blood vessel functionality parameters-Vasodilation/Constriction Index (VDC), Vascular Resistance Index (VR), and Volume Reactivity Index (VRx) will not be used for any medical decisions. This evaluation will be conducted in addition to any other tests, procedures, and/or scans ordered by the participants treating physician. Patients will be required to meet inclusion criteria and meet none of the exclusion criteria. This population is representative of the general population that is expected to use the device in clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville Health

Louisville, Kentucky, 40202, United States

RECRUITING

Related Publications (1)

• Longhitano Y, Iannuzzi F, Bonatti G, Zanza C, Messina A, Godoy D, Dabrowski W, Xiuyun L, Czosnyka M, Pelosi P, Badenes R, Robba C. Cerebral Autoregulation in Non-Brain Injured Patients: A Systematic Review. Front Neurol. 2021 Nov 16;12:732176. doi: 10.3389/fneur.2021.732176. eCollection 2021.

  PMID: 34899560 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 22, 2024
• Study Start: November 17, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)