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| ID | Type | Description | Link |
|---|---|---|---|
| Pending | Other Grant/Funding Number | Edwards Lifesciences Corp. |
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| Name | Class |
|---|---|
| Edwards Lifesciences | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| - Non-Invasive Near-infrared Spectroscopy (NIRS) device (HEM1 with Foresight Elite Sensor) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Limit of Autoregulation (LLA) | Successful calculations of moving Lower Limit of Autoregulation (LLA) for all three algorithms | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of delayed cerebral ischemia (DCI) to the average LLA | Correlation of clinical course of delayed cerebral ischemia (DCI) to average LLA | 21 days |
| Change in time under LLA | Correlation in time under LLA |
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Inclusion Criteria:
Exclusion Criteria:
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Neurological Intensive Care Unit (NICU) patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LaShun L. Horn, M.S. | Contact | 205-996-2606 | llhorn@uabmc.edu | |
| Roxana Santander-Chapeta | Contact | 205-975-2846 | rsantanderchapeta@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Weifeng Song, M.D., Ph.D | The University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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|
| 21 days |
| Change in dose under LLA | Correlation in dose under LLA | 21 days |
| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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