The Role of Hyperoxia in Acute Ischemic Stroke

Study Overview
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Brief Summary
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This study is being conducted to evaluate the potential therapeutic role of hyperoxia when applied in the immediate ischemic period following a stroke in the controlled Emergency Department setting. The study will evaluate the effects of hyperoxia in stroke patients on the production of markers of free radical damage and inflammatory markers associated with hyperoxic lung injury.

Official Title
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The Role of Hyperoxia in the Emergency Department Treatment of Acute Ischemic Stroke

Conditions
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Stroke, Acute

Intervention / Treatment
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* Other: Oxygen
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form from patient or legal authorized representative (LAR) Subject or LAR stated willingness to comply with all study procedures and availability for the duration of the study Males and females (of unlikely childbearing capacity) aged over 18 years. Exhibiting signs and physical examination findings suggestive of an acute ischemic infarction (either a or b) A target mismatch profile of CT-perfusion or MRI determined by RAPID automated software to have a ratio of PWITmax>6 lesion volume/DWI lesion volume >1.2 and an NIHSS >/=1 A RAPID automated software calculated non-contrast CT-head ASPECT score of 10 and LKW ≤12 hours (in patients with symptoms discovered upon waking, the LKW is defined at the midpoint between going to sleep and awakening based on previous studies that suggest most strokes during sleep occur close to awakening) Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen Exclusion Criteria: Current use of supplemental oxygen Prisoner Documented blood glucose <70mg/dL Concurrent treatment with another investigational drug or other intervention Documented history of any of the following chronic respiratory illness that require pulmonary vasodilators or supplemental oxygen at baseline: Chronic Obstructive Pulmonary Disorder (COPD), Emphysema, Interstitial Lung Disease, Restrictive Lung Disease, Pulmonary Hypertension Documented history of any of the following autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, primary biliary cholangitis, multiple sclerosis, inflammatory bowel disease Currently being treated for an acute myocardial infarction and/or decompensated heart failure at the onset of initial ED presentation as reported by the ED provider Plans for treatment with either IV tPA (alteplase) or endovascular therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperoxia<br>Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. | Other: Oxygen<br>* 100% Oxygen air<br>|
| Placebo Comparator: Placebo<br>will receive 15liters per minute medical air via a partial non-rebreather facemask. | Other: placebo<br>* medical air<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean time to randomization and initiation of intervention | Patient arrival to the emergency department will be documented and recorded. They will be screened for participation by study personnel. Once consented and randomized, the time of initiation of intervention will be recorded. The mean time from emergency department presentation to initiation of therapy will be determined. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean ratio of the volume of initial hypoperfused tissue to final infarct volume | The total area of hypoperfused brain tissue on initial imaging will be compared to the final infarct volume. This ratio of hypoperfused to final infarct volume will be compared between treatment groups. | one week | 
| Change in mean NIHSS | National Institute of Health Stroke Scale (NIHSS) score will be measured at presentation, 4-hours after intervention and 24-hours after intervention. The change in NIHSS over time will be compared between groups. The NIHSS score is a range of scores from 0-42 with higher scores indicating a more severe stroke and disability. | baseline to 24-hours |