Normobaric Oxygen Therapy in Acute Ischemic Stroke Trial
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: NBO (Normobaric Oxygen); Room Air
Intervention description: High-flow oxygen delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.; Room Air delivered via a facemask. A total of 240 individuals with acute ischemic stroke will be randomized 1:1 to receive either room air or oxygen administered at 30-45 L/min via a simple facemask for 8 hours.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 85.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ischemic stroke; normobaric oxygen therapy

Summary:

      The purpose of this study is to compare the safety and efficacy of treating individuals with
      acute ischemic stroke with normobaric oxygen therapy (NBO, given within 9 hours of symptom
      onset), to standard medical treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 18 years.

          -  Acute ischemic stroke in whom treatment can potentially be started within 9 hours
             after symptom onset. If the symptom onset time is unknown, the time of onset will be
             defined as the midpoint between the time when the subject was last seen neurologically
             intact, and when found to have a neurological deficit.

          -  National Institutes of Health Stroke Scale (NIHSS) score 4 or greater.

        Exclusion Criteria:

          -  Patients being actively considered for intravenous or intra-arterial thrombolysis will
             be excluded.

          -  Patients likely to have acute stroke intervention such as carotid endarterectomy or
             stent or angioplasty, hemicraniectomy, etc.

          -  Rapidly improving neurological deficits (transient ischemic attack).

          -  Known history of severe chronic obstructive pulmonary disease (Forced Expiratory Vital
             Capacity less than 1.0 or oxygen dependent).

          -  More than 3 L/min oxygen required to maintain peripheral arterial oxygen saturation
             above 92%.

          -  New York Heart Association Class III heart failure.

          -  Endotracheal intubation prior to enrollment or impending need for artificial
             ventilation.

          -  Coma (National Institutes of Health Stroke Scale item 1a score of 3).

          -  Suspected seizure at or after onset of stroke, or a known active seizure disorder.

          -  Blood glucose below 50 mg/dL or greater than 250 mg/dL prior to enrollment.

          -  Concurrent severe non-stroke medical illness requiring admission to a non-neurological
             intensive care unit

          -  Expected survival less than 90 days.

          -  Any condition that might limit neurological assessment or follow-up in the opinion of
             the investigator.

          -  Pre-menopausal women with a positive pregnancy blood test performed at admission.

          -  Inability to obtain consent from the patient or legally authorized representative.

          -  Active participation in another intervention study (e.g. investigational drug trial).

          -  Proven alternate etiology for stroke-like symptoms.