Trial Outcomes & Findings for The Role of Hyperoxia in Acute Ischemic Stroke (NCT NCT03904017)

Last Updated: 2024-05-16

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

baseline

Results posted on

2024-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Hyperoxia Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. Oxygen: 100% Oxygen air	Placebo will receive 15liters per minute medical air via a partial non-rebreather facemask. placebo: medical air
Overall Study STARTED	3	10
Overall Study COMPLETED	3	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Hyperoxia in Acute Ischemic Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hyperoxia n=3 Participants Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. Oxygen: 100% Oxygen air	Placebo n=10 Participants will receive 15liters per minute medical air via a partial non-rebreather facemask. placebo: medical air	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	60 years STANDARD_DEVIATION 17.4 • n=5 Participants	71.6 years STANDARD_DEVIATION 14.3 • n=7 Participants	68.9 years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	10 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Population: The time from ED arrival to initiation of treatment arm was measured in minutes for 3 patients receiving hyperoxia and 10 patients receiving placebo

Outcome measures

Outcome measures
Measure	Hyperoxia n=3 Participants Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. Oxygen: 100% Oxygen air	Placebo n=10 Participants will receive 15liters per minute medical air via a partial non-rebreather facemask. placebo: medical air
Mean Time to Randomization and Initiation of Intervention	96.7 minutes Standard Deviation 27.3	75.1 minutes Standard Deviation 14.8

SECONDARY outcome

Timeframe: one week

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Hyperoxia n=3 Participants Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. Oxygen: 100% Oxygen air	Placebo n=6 Participants will receive 15liters per minute medical air via a partial non-rebreather facemask. placebo: medical air
Mean Ratio of the Volume of Initial Hypoperfused Tissue to Final Infarct Volume	2.17 ratio Standard Deviation 0.69	7.76 ratio Standard Deviation 10.7

SECONDARY outcome

Timeframe: baseline to 24-hours

Population: 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

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.

Outcome measures

Outcome measures
Measure	Hyperoxia n=3 Participants Will receive 15liters per minute supplemental oxygen via a partial non-rebreather facemask. Oxygen: 100% Oxygen air	Placebo n=10 Participants will receive 15liters per minute medical air via a partial non-rebreather facemask. placebo: medical air
Change in Mean NIHSS	2 score on a scale Standard Deviation 0	1.2 score on a scale Standard Deviation 3.1

Adverse Events

Hyperoxia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Layne Dylla

University of Colorado

Phone: 303-724-1716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place