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Using normobaric oxygen to improve outcomes in acute ischemic stroke patients

Adjuvant Normobaric Hyperoxia in Acute Ischemic Stroke Patients Transferred for Thrombectomy

Phase 3 Interventional Capital Medical University · NCT06666764

This study is testing if giving extra oxygen to people with acute ischemic stroke during their transfer for treatment can help them recover better and improve their overall function after three months.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1500 (estimated)
Ages18 Years and up
SexAll
SponsorCapital Medical University Academic / other
Locations112 sites (Beijing, Beijing Municipality and 111 other locations)
Trial IDNCT06666764 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of normobaric oxygen (NBO) therapy in patients with acute ischemic stroke (AIS) who are being transferred for endovascular therapy (EVT). The research focuses on the potential neuroprotective effects of NBO, which may enhance functional outcomes by improving cerebral metabolism and reducing infarct volume. Participants will be monitored for their functional status at three months post-treatment, with a specific emphasis on achieving a favorable modified Rankin Scale score. The study includes patients with significant stroke symptoms and specific imaging criteria to ensure appropriate selection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with acute ischemic stroke symptoms and specific imaging findings indicating large vessel occlusion.

Not a fit: Patients with significant pre-stroke disability or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for patients suffering from acute ischemic stroke.

How similar studies have performed: While the use of normobaric oxygen is a novel approach in this context, previous studies have indicated potential benefits of oxygen therapy in various neurological conditions.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age at least 18 years old;
2. Signs and symptoms are consistent with a new acute stroke, with low possibility of stroke mimics (e.g., no sudden coma, prior seizure disorder, suspected hypoglycemia);
3. No prior stroke in the last 3 months;
4. Time from stroke onset (last seen well) to randomization is within 9 hours;
5. (1) Baseline NIHSS score at 6 or more and Intracranial ICA or MCA-M1 or MCA-M2 dominant occlusion, with or without tandem cervical carotid stenosis or tandem cervical occlusion, confirmed by preoperative CTA (or MRA, DSA) and consistent with signs and symptoms; or (2) Baseline NIHSS score at 6 or more with a hyperdense MCA sign on non-contrast CT; or (3) Baseline NIHSS score at 12 or more;
6. NIHSS score 0 or 1 in the section of level of consciousness;
7. No significant pre-stroke disability (pre-stroke mRS 0--1);
8. ASPECTS at least 6 on non-contrast CT;
9. Patient is planned for transfer to a EVT-capable hospital for EVT;
10. Signed informed consent from the patient or the legally authorized representative (LAR).

Exclusion Criteria:

1. Known history of severe chronic obstructive pulmonary disease (FEV1 less than 1.0), New York Heart Association (NYHA) Heart Failure Class III or IV, acute pulmonary infection or aspiration pneumonia, prior to enrollment;
2. Respiratory rate \<= 10 or \>= 30 breaths per minute;
3. Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline;
4. Seizure at stroke onset;
5. Exhibiting symptoms of vomiting, or severe headache, or unconscious;
6. Rapidly improving neurological deficits or transient ischemic attack prior to consent;
7. Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
8. Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation;
9. Woman of childbearing potential known to be pregnant or with a positive pregnancy test;
10. Life expectancy \< 90 days due to comorbidity;
11. Unlikely to complete the 90-day follow-up;
12. Participating in another clinical treatment trial, or completed participation within prior 30 days;
13. Receiving other cerebral protective agent (e.g., edaravone dexborneol, n-butylphthalide);
14. Evidence of acute intracranial hemorrhage on CT/MRI;
15. Significant mass effect with midline shift, defined as any deviation of midline structures such as the septum pellucidum, is observed on CT/MRI scans.

Where this trial is running

Beijing, Beijing Municipality and 111 other locations

+62 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic Strokeischemic strokecerebral protection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.