Overview
- The goal of this clinical trial is to evaluate the efficacy and safety of hyperbaric oxygen (HBO)in stroke patients after endovascular treatment
- The main questions it aims to answer is:
Whether HBO can improve the prognosis of ischemic stroke patients after endovascular treatment? 3. Participants will:
receive HBO (1.6 Atmosphere Absolute，1.6ATA)，Once a day, for 1 hour each time, for 5 days a week (it can be non-consecutive days), the total course of treatment is 10 times.
undergo three scheduled face to face or telephone follow-up assessments during the 12-month period following HBO.
Eligibility
Inclusion Criteria:
- 35-75 years
- The symptoms and signs are consistent with acute anterior circulation ischemic stroke. The immediate postoperative angiographic recanalization grade was ≥ 2b.
- Neurological deficit score at the time of enrollment: 5 ≤ NIHSS ≤ 15 points
- Consciousness status (NIHSS 1a-1b items): 0-1 point
- Pre-stroke functional status (mRS score): 0-1
- Time from surgery to randomization grouping: ≤ 72 hours
- Patient or legal representative who signed the informed consent form
- Preoperative CT angiography or magnetic resonance angiography confirmed large vessel occlusion (internal carotid artery or middle cerebral artery M1 segment) that was consistent with the symptoms and signs; And the area supplied by the middle cerebral artery in the brain is less than 1/3.
- A lberta S troke P rogram E arly C T S core ≥ 6
Exclusion Criteria:
- Subjects with HBO contraindications or intolerance
- Postprocedural imaging identified either procedure-related subarachnoid hemorrhage or hemorrhagic transformation
- Based on the medical history, it is suspected that the cerebral embolism is caused by sepsis or infective endocarditis
- Expected lifespan \< 90 days
- Severe heart, liver and kidneys failure
- Pregnancy
- Hereditary or acquired bleeding tendency, deficiency of coagulation factors, recent use of oral anticoagulants with an international normalized ratio (INR) \> 3 or activated partial thromboplastin time (APTT) exceeding the normal value by more than 3 times
- Baseline platelet count \< 50×10 9/L
- Baseline blood glucose is less than 2.78 mmol/L or greater than 22.2 mmol/L.
- Unstable vital signs (heart rate ≤ 50 beats/min or ≥ 120 beats/min, oxygen saturation ≤ 90%, respiration ≥ 30 breaths/min or ≤ 10 breaths/min);
- Hypertension that cannot be controlled by medication: Systolic blood pressure ≥ 160 mmHg, or diastolic blood pressure ≥ 100 mmHg;
- Suspected of having acute myocardial infarction;
- Currently involving in the research of other projects related to drugs or medical devices.
- CT or MRI scans revealed intracranial tumors (except for cerebellar meningiomas) and intracranial arteriovenous malformations.
- Based on the medical history and CT or MRI findings, a diagnosis of internal carotid artery dissection or aortic dissection is suspected;
- Based on the medical history and CT or MRI findings, cerebral vasculitis is suspected.
- Based on the clinical evidence of multiple vascular regions being occluded (either in the bilateral anterior circulation or anterior/posterior circulation) or bilateral infarction or multi-region infarction as detected by CT angiography or magnetic resonance angiography;
- CT or magnetic resonance imaging shows a significant midline shift effect (\> 0.5 cm);
- CT angiography or magnetic resonance angiography confirmed the presence of cerebral vasculitis or cerebral vasculitis syndrome;
