The Role of Hyperoxia in Acute Ischemic Stroke

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03904017
• Other study ID #: 20-0486
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2019
• Est. completion date: May 2023

Study information

• Verified date: April 2022
• Source: University of Colorado, Denver
• Contact: Layne Dylla, MD, PHD
• Phone: 720-848-6777
• Email: layne.dylla[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperoxia
• Ischemic Stroke
• Stroke
• Stroke, Acute

Intervention

Other:
• Oxygen
100% Oxygen air
• placebo
medical air

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	University of Colorado Hospital - Memorial Central	Colorado Springs	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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