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Failure to enroll
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperoxia | Experimental | Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. |
|
| Placebo | Placebo Comparator | will receive 15liters per minute medical air via a partial non-rebreather facemask. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Other | 100% Oxygen air |
| |
| placebo |
| 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 |
| 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 |
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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)
Normoxic; a pulse oximetry of 94% or greater at time of screening without the use of supplemental oxygen
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| University of Colorado Hospital - Memorial Central |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hyperoxia | Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. Oxygen: 100% Oxygen air |
| FG001 | Placebo | will receive 15liters per minute medical air via a partial non-rebreather facemask. placebo: medical air |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hyperoxia | Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. Oxygen: 100% Oxygen air |
| BG001 | Placebo | will receive 15liters per minute medical air via a partial non-rebreather facemask. placebo: medical air |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The time from ED arrival to initiation of treatment arm was measured in minutes for 3 patients receiving hyperoxia and 10 patients receiving placebo | Posted | Mean | Standard Deviation | minutes | baseline |
|
Subjects were monitored for adverse events during the 24hours that they were under study observation. A 90-day modified Rankin was collected and any deaths at this time were noted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hyperoxia | Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. Oxygen: 100% Oxygen air |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Layne Dylla | University of Colorado | 303-724-1716 | layne.dylla@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2021 | Mar 2, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 18, 2022 | Mar 2, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Other |
medical air |
|
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. |
| baseline to 24-hours |
| Colorado Springs |
| Colorado |
| 80909 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
will receive 15liters per minute medical air via a partial non-rebreather facemask. placebo: medical air |
|
|
| 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. | Subjects (3 hyperoxia and 6 placebo) who were able to complete the MRI within one week had the volume of the total hypoperfused brain tissue and the final infarct volume measured using RAPID automated software. | Posted | Mean | Standard Deviation | ratio | one week |
|
|
|
| Secondary | Change in Mean NIHSS | 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. | The change in NIHSS from baseline to 24 hours was calculated for 3 hyperoxia and 10 placebo subjects. The mean and standard deviation for both groups was calculated | Posted | Mean | Standard Deviation | score on a scale | baseline to 24-hours |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Placebo | will receive 15liters per minute medical air via a partial non-rebreather facemask. placebo: medical air | 1 | 10 | 0 | 10 | 0 | 10 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |