Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
Continuous Assessment of Cerebral Autoregulation in Subarachnoid Hemorrhage (SAH) Patients Using Cerebral Oximetry Index and Hemoglobin Volume Reactivity Index
The goal of this observational study is to continuously assess cerebral autoregulation in patients with subarachnoid hemorrhage (SAH) using cerebral oximetry index (COx) and hemoglobin volume reactivity index (HVx). The main question it aims to answer is: Whether optimal perfusion pressure is dynamic and changes with time in patients with SAH, and that autoregulation is disrupted in patients during the course of SAH, contributing to delayed cerebral ischemia (DCI).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: LaShun L. Horn, M.S.
- Phone Number: 205-996-2606
- Email: llhorn@uabmc.edu
Study Contact Backup
- Name: Roxana Santander-Chapeta
- Phone Number: 205-975-2846
- Email: rsantanderchapeta@uabmc.edu
Study Locations
-
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Alabama
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Birmingham, Alabama, United States, 35294
- The University of Alabama at Birmingham
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Contact:
- Weifeng Song, M.D., Ph.D
- Phone Number: 205-934-4699
- Email: wsong@uabmc.edu
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Principal Investigator:
- Weifeng Song, M.D., Ph.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Neurological Intensive Care Unit (NICU) patients
Description
Inclusion Criteria:
- Patients aged 18 to 89 years who are admitted to the Neurological Intensive Care Unit (Neuro ICU) between March 2025 and December 2026 for aneurysmal subarachnoid hemorrhage (SAH).
Exclusion Criteria:
- Patients under 18 years old
- Prisoners
- Pregnant women
- Patients enrolled in concurrent ongoing interventional trial
- Students of UAB
- Employees of UAB
- Patients who undergoes frontal decompression surgery resulting bone flap deficit where NIRS monitoring pads could not be applied.
Study Plan
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Aneurysmal subarachnoid hemorrhage (SAH) patients
The study will be conducted on patients aged 18 to 89 years admitted to the Neurological Intensive Care Unit (ICU) with a Aneurysmal subarachnoid hemorrhage (SAH). The study will use near-infrared spectroscopy (NIRS) monitors (which is outside standard of care) and transcranial doppler (TCD, only when available and is standard of care) that will be attached to these patients. The data from these devices will be used solely for analysis after the patients have been discharged. |
Near-Infrared Spectroscopy (NIRS) monitors, provided by Edwards Lifesciences, is a monitoring technique. It will be connected to consented patients, automatically capturing brain oxygen as waveform output, and stored in Sickbay system. The NIRS is a non-invasive monitoring method, in which adhesive pads will be applied to forehead. 4 hours continuous monitoring will be recorded on day 1 after SAH (or on presence to NICU), then every three days from day 3 to day 14 (within the DCI window), to 1 to 2 recordings from day 15 to day 21. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Lower Limit of Autoregulation (LLA)
Time Frame: 21 days
|
Successful calculations of moving Lower Limit of Autoregulation (LLA) for all three algorithms |
21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of delayed cerebral ischemia (DCI) to the average LLA
Time Frame: 21 days
|
Correlation of clinical course of delayed cerebral ischemia (DCI) to average LLA |
21 days
|
|
Change in time under LLA
Time Frame: 21 days
|
Correlation in time under LLA |
21 days
|
|
Change in dose under LLA
Time Frame: 21 days
|
Correlation in dose under LLA |
21 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Weifeng Song, M.D., Ph.D, The University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Hemorrhage
- Intracranial Hemorrhages
- Pathological Conditions, Signs and Symptoms
- Subarachnoid Hemorrhage
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Diagnostic Imaging
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Spectroscopy, Near-Infrared
Other Study ID Numbers
- IRB-300014488
- HCP-135292794 (Other Grant/Funding Number: Edwards Lifesciences Corp.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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