The Role of Hyperoxia in Acute Ischemic Stroke

NCT ID: NCT03904017

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-28
• Study Completion Date: 2023-02-01

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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hyperoxia

Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask.

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: OTHER

100% Oxygen air

Placebo

will receive 15liters per minute medical air via a partial non-rebreather facemask.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

medical air

Interventions

Oxygen

100% Oxygen air

Intervention Type: OTHER

placebo

medical air

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Provision of signed and dated informed consent form from patient or legal authorized representative (LAR)

2. Subject or LAR stated willingness to comply with all study procedures and availability for the duration of the study

3. Males and females (of unlikely childbearing capacity) aged over 18 years.

4. 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)

5. Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen

Exclusion Criteria

1. Current use of supplemental oxygen

2. Prisoner

3. Documented blood glucose <70mg/dL

4. Concurrent treatment with another investigational drug or other intervention

5. 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

6. Documented history of any of the following autoimmune diseases: systemic lupus erythematosus, rheumatoid arthritis, scleroderma, primary biliary cholangitis, multiple sclerosis, inflammatory bowel disease

7. 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

8. Plans for treatment with either IV tPA (alteplase) or endovascular therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Colorado

Aurora, Colorado, United States

University of Colorado Hospital - Memorial Central

Colorado Springs, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20-0486

Identifier Type: -

Identifier Source: org_study_id