RecruitingPhase 3

Normobaric Oxygen in AIS Transferred for EVT

China1,500 participantsStarted 2024-12-13

Plain-language summary

The primary objective of this study is to estimate the efficacy and safety of NBO on 3-month functional outcome after acute ischemic stroke

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age at least 18 years old;
✓. 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);
✓. No prior stroke in the last 3 months;
✓. Time from stroke onset (last seen well) to randomization is within 9 hours;
✓. (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;
✓. NIHSS score 0 or 1 in the section of level of consciousness;
✓. No significant pre-stroke disability (pre-stroke mRS 0--1);
✓. ASPECTS at least 6 on non-contrast CT;

✕. 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;
✕. Respiratory rate \<= 10 or \>= 30 breaths per minute;
✕. Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline;
✕. Seizure at stroke onset;
✕. Exhibiting symptoms of vomiting, or severe headache, or unconscious;
✕. Rapidly improving neurological deficits or transient ischemic attack prior to consent;
✕. Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
✕. Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation;

Level of disability measured by modified Rankin scale (mRS) score

Timeframe: 90 days, 1 year after randomization

NCT IDNCT06666764

SponsorCapital Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Lan Liu, PhD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age at least 18 years old;
✓. 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);
✓. No prior stroke in the last 3 months;
✓. Time from stroke onset (last seen well) to randomization is within 9 hours;
✓. (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;
✓. NIHSS score 0 or 1 in the section of level of consciousness;
✓. No significant pre-stroke disability (pre-stroke mRS 0--1);
✓. ASPECTS at least 6 on non-contrast CT;

✕. 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;
✕. Respiratory rate \<= 10 or \>= 30 breaths per minute;
✕. Oxygen-dependence at baseline to maintain SaO2 \> 95% or intubation at baseline;
✕. Seizure at stroke onset;
✕. Exhibiting symptoms of vomiting, or severe headache, or unconscious;
✕. Rapidly improving neurological deficits or transient ischemic attack prior to consent;
✕. Signs and symptoms suggestive of subarachnoid hemorrhage, even if CT scan is normal;
✕. Evidence of intracranial tumor (except small meningioma) or arteriovenous malformation;