Using normobaric oxygen to improve outcomes in acute ischemic stroke patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Fujian Medical University First Affiliated Hospital
  Fuzhou, Fujian, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Fujian Minhou County Hospital
  Fuzhou, Fujian, China Recruiting
• Fuqing Hospital
  Fuzhou, Fujian, China Recruiting
• Fuqing Second Hospital
  Fuzhou, Fujian, China Recruiting

+62 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Lan Liu, PhD
• Email: liulan1815@outlook.com
• Phone: 8683911991

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.