Could a simple oxygen mask boost stroke recovery hours after symptoms start?

NCT ID NCT07717216

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This trial tests whether giving high-concentration oxygen during a clot-removal procedure can improve recovery for people having a major stroke who arrive at the hospital 6 to 24 hours after symptoms began. Participants are randomly assigned to receive either the oxygen therapy or standard care alongside the procedure. The goal is to see if the extra oxygen protects brain tissue and leads to better function 90 days later.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high-concentration oxygen (normobaric hyperoxia) delivered through a mask or ventilator
What this could lead to
If it works, this could offer a simple, low-cost way to improve recovery for stroke patients who miss the early treatment window.
What could go wrong
This is a mid-stage trial, and earlier results may not hold up. Oxygen therapy could also cause side effects like lung irritation or worsen outcomes in some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 314 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18 years or older. 2. Clinical signs and symptoms consistent with acute anterior-circulation ischemic stroke, with a National Institutes of Health Stroke Scale (NIHSS) score of 10 or greater at the time of randomization. 3. Pre-stroke modified Rankin Scale (mRS) score of 0 or 1. 4. Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of 6 or greater on baseline non-contrast computed tomography or diffusion-weighted magnetic resonance imaging. 5. Eligible for endovascular therapy according to current guideline-recommended clinical practice and the judgment of the treating stroke team and neurointerventional team. 6. Randomization can be completed between 6 and 24 hours after the time the participant was last known well. Randomization and initiation of the study intervention must not cause an avoidable delay in endovascular therapy. 7. Pre-procedural computed tomography angiography or magnetic resonance angiography confirms large-vessel occlusion consistent with the participant's neurological deficits, involving one of the following: internal carotid artery or M1 segment of the middle cerebral artery. 8. Baseline level of consciousness score on item 1a of the NIHSS is 0 or 1. 9. Written informed consent has been obtained from the participant or the participant's legally authorized representative. Exclusion Criteria: * General Exclusion Criteria 1. NIHSS score of less than 10 at the time of randomization; substantial neurological improvement such that the participant is no longer considered eligible for endovascular therapy; or imaging-confirmed spontaneous recanalization with no remaining treatable target-vessel occlusion. 2. Seizure at stroke onset when the current neurological deficits are considered primarily attributable to a postictal state, or when a reliable baseline NIHSS assessment cannot be obtained. 3. Active clinically significant bleeding or a bleeding diathesis that, in the judgment of the investigator or treating clinical team, makes endovascular therapy or participation in the study unsafe. 4. Platelet count below 100 × 10⁹/L. 5. Clinically significant coagulation abnormality, anticoagulant exposure, or coagulation-factor deficiency that, according to the local standard of care at the participating center, makes the participant ineligible for endovascular therapy. 6. Severe or end-stage cardiac, hepatic, or renal dysfunction that is expected to substantially affect 90-day survival, functional outcome assessment, or the safety of study participation. 7. Persistent baseline blood glucose below 50 mg/dL (2.78 mmol/L) or above 400 mg/dL (22.20 mmol/L) after appropriate initial evaluation or correction. 8. Persistent systolic blood pressure above 185 mmHg or diastolic blood pressure above 110 mmHg despite appropriate antihypertensive treatment. 9. Life expectancy of less than 90 days because of a pre-existing disease or other underlying medical condition. 10. Known pregnancy. 11. Any of the following clinically significant respiratory diseases or conditions that, in the investigator's judgment, may make high-concentration oxygen therapy unsafe or interfere with reliable administration of the study intervention:chronic obstructive pulmonary disease; acute pulmonary infection; acute respiratory distress syndrome;clinically significant pleural effusion;chronic hypercapnic respiratory failure; another respiratory condition that may affect the safety of high-concentration oxygen therapy or the administration of the mask-based intervention. 12. Any of the following conditions before randomization: requirement for supplemental oxygen at a flow rate greater than 3 L/min to maintain peripheral oxygen saturation above 94%;requirement for noninvasive ventilatory support because of respiratory failure; or requirement for invasive mechanical ventilation because of respiratory failure. 13. Persistent clinically significant vital-sign instability after initial treatment, including but not limited to: heart rate of 50 beats per minute or lower or 120 beats per minute or higher; peripheral oxygen saturation of 90% or lower;respiratory rate of 10 breaths per minute or lower or 30 breaths per minute or higher; or other unstable vital signs considered by the investigator to potentially compromise participant safety. 14. Active vomiting, a high risk of aspiration, or inability to tolerate the study mask, except for participants who require clinically indicated endotracheal intubation and mechanical ventilation. 15. Active gastrointestinal bleeding. 16. History of a severe adverse reaction to iodinated contrast media that cannot be adequately managed with premedication, an alternative contrast strategy, or other appropriate clinical measures and therefore precludes endovascular therapy. 17. Current participation in another interventional clinical trial that may interfere with the study intervention, safety assessment, or evaluation of study outcomes. 18. Any other disease, condition, or circumstance that, in the investigator's judgment, makes the participant unsuitable for the study or may interfere with study treatment, participant safety, or outcome assessment. The specific reason must be documented. * Imaging Exclusion Criteria 1. Evidence of intracranial hemorrhage on baseline computed tomography or magnetic resonance imaging, including but not limited to intraparenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or epidural hemorrhage. 2. Failure to meet the prespecified perfusion-mismatch imaging criteria, including an ischemic core volume of 70 mL or greater. 3. Pre-randomization computed tomography angiography or magnetic resonance angiography demonstrates abnormal vascular anatomy or excessive vascular tortuosity such that, in the judgment of the treating neurointerventionalist, the target vessel cannot be safely accessed with endovascular devices or endovascular therapy is technically infeasible. 4. Based on the medical history, computed tomography angiography, magnetic resonance angiography, or other imaging findings, any of the following is suspected to be the primary cause of the index stroke and is considered to make endovascular therapy inappropriate or unsafe: cerebral vasculitis; aortic dissection; cervical arterial dissection; or intracranial arterial dissection. 5. Intracranial vascular occlusions involving multiple independent vascular territories, bilateral anterior-circulation infarction, or simultaneous anterior- and posterior-circulation infarction. A tandem lesion consisting of cervical internal carotid artery occlusion together with an intracranial large-vessel occlusion in the same vascular territory will not be automatically excluded if the treating neurointerventionalist considers endovascular therapy appropriate. 6. Confirmed moyamoya disease or moyamoya syndrome. 7. Substantial cerebral edema, mass effect, or midline shift on baseline computed tomography or magnetic resonance imaging. 8. Intracranial neoplasm that may affect the 90-day functional outcome, increase the risk of hemorrhage, or interfere with study assessment. A small, asymptomatic meningioma may be permitted at the investigator's discretion.

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Conditions

The condition(s) this trial relates to.

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