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RecruitingNCT06511804Mespere ICPUpdated May 30, 2025

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

An observational study in Brain Injuries, Intracranial Pressure Increase and Monitoring, sponsored by University of Louisville. Recruiting at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by University of Louisville · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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 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:

  1. Regional Tissue Oxygen Saturation (StO2): This parameter provides data on regional hemoglobin oxygen saturation in the cerebral tissue beneath the sensor. It is captured using our cerebral oximetry sensors and offers critical insights into tissue oxygenation.
  2. Blood Volume Index (BVI): BVI provides information on the regional blood-to-tissue volume ratio in the cerebral tissue beneath the sensor, again captured using our cerebral oximetry sensors. BVI is instrumental in understanding blood volume dynamics in the brain.
  3. Mean Arterial Pressure (MAP) and Systolic Blood Pressure (SBP): Real-time MAP and SBP data will be pulled from the Philips patient monitor, providing a comprehensive overview of the patient's circulatory status.
  4. Intracranial Pressure (ICP): Similar to MAP and SBP, real-time ICP data will also be pulled from the Philips patient monitor, offering valuable insights into intracranial dynamics.
  5. Vasodilation/Constriction Index (VDC): VDC is a derived parameter from BVI, signifying the relative change in blood vessel cross-sectional area. An increase indicates vessel dilation, while a decrease indicates vessel constriction. This index offers insights into cerebral vessel reactivity.
  6. Vascular Resistance Index (VR): VR is a derived parameter from BVI, indicating the percent change in blood vessel resistance based on the Hagen-Poiseuille formula. VR helps assess the resistance to blood flow within cerebral vessels.
  7. Volume Reactivity Index (VRx): VRx is a real-time moving Pearson Correlation Coefficient between Blood Volume Index (BVI) derived from our Cerebral Oximetry sensors and MAP. This parameter is derived from Pressure Reactivity Index (PRx), making VRx a non-invasive alternative to the invasive PRx. VRx is used to assess autoregulation.
02

Conditions studied

  • Brain Injuries
  • Intracranial Pressure Increase
  • Monitoring

Keywords

  • intracranial pressure
  • monitoring
  • noninvasive
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's planned enrollment of 25 is below the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No

Interventions

  • DeviceIntracranial Pressure Noninvasive Monitoring

    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.

06

What researchers measure

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

    Time frame: 1 hour

07

Study locations

1 of 1 sites recruiting
  • University of Louisville Health
    Louisville, Kentucky 40202, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 34899560 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06511804
Lead sponsor
University of Louisville
Responsible party
Jiapeng Huang (Professor, University of Louisville) — Principal investigator
First posted
Jul 22, 2024
Start date
Nov 17, 2024
Primary completion
Dec 30, 2025 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
May 30, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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