Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: - Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor).
- Who it may be relevant to
- Registry conditions: Subarachnoid Hemorrhage, Aneurysmal. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Assessment of Cerebral Autoregulation in Subarachnoid Hemorrhage (SAH) Patients Using Cerebral Oximetry Index and Hemoglobin Volume Reactivity Index
Overview
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).
Interventions
- Device - Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor)
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 t
Primary outcome measures
- Change in Lower Limit of Autoregulation (LLA) [Time frame: 21 days]
Secondary outcome measures (3)
- Change of delayed cerebral ischemia (DCI) to the average LLA [Time frame: 21 days]
- Change in time under LLA [Time frame: 21 days]
- Change in dose under LLA [Time frame: 21 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- The University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT06932640 · IRB-300014488 · HCP-135292794