The Role of Hyperoxia in Acute Ischemic Stroke

Not Applicable

Terminated

Brief Summary: 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.

Recruitment & Eligibility

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)
1. 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
2. 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

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	will receive 15liters per minute medical air via a partial non-rebreather facemask.
Hyperoxia	Oxygen	Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask.

Primary Outcome Measures

Name	Time	Method
Mean Time to Randomization and Initiation of Intervention	baseline	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.

Secondary Outcome Measures

Name	Time	Method
Mean Ratio of the Volume of Initial Hypoperfused Tissue to Final Infarct Volume	one week	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.
Change in Mean NIHSS	baseline to 24-hours	National Institute of Health Stroke Scale (NIHSS) score will be measured at presentation and 24-hours after intervention. The change in NIHSS from presentation to 24-hours 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.

Locations (2): University of Colorado
🇺🇸
Aurora, Colorado, United States
University of Colorado Hospital - Memorial Central
🇺🇸
Colorado Springs, Colorado, United States