Normobaric Hyperoxia Combined With Endovascular Therapy in Patients With Stroke Within 6 Hours of Onset:Longterm Outcome (NBOL)
Stroke, Acute, Hypoxia-Ischemia, Brain, ENDOVASCULAR TREATMENT
About this trial
This is an interventional treatment trial for Stroke, Acute
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old.
- The clinical symptoms and signs are consistent with acute anterior circulation large vessel occlusion;
- NIHSS score ≥ 10 points;
- (Level of consciousness) NIHSS score 0 or 1;
- The time from onset to randomization is within 6 hours of onset;
- The mRS score before stroke is 0-1;
- The patient has good compliance and can complete the operation with local anesthesia;
- The patient can cooperate with this study and follow-up in the future
- Patient and family members sign informed consent。-
Exclusion Criteria:
- Rapid neurological function improvement, NIHSS score less than 10 points, or evidence of vessel recanalization prior to randomization;
- Seizures at stroke onset;
- Intracranial hemorrhage;
- Symptoms suggestive of subarachnoid hemorrhage, even if CT scan was normal;
- Platelet count of less than 100,000 per cubic millimeter;
- Severe hepatic or renal dysfunction;
- Active and chronic obstructive pulmonary disease or acute respiratory distress syndrome;
- >3 L/min oxygen required to maintain peripheral arterial oxygen saturation (SaO2) 95% as per current stroke management guidelines;
- Medically unstable;
- Life expectancy<90 days;
- Evidence of intracranial tumor;
Sites / Locations
- Baojun HouRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
NBO group Normobaric Hyperoxia combined with endovascular mechanical thrombectomy
Control group Inhale air placebo plus endovascular mechanical thrombectomy
Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30minutes after admission) at a ventilation rate of 10L/min using a sealed non-ventilating oxygen storagemask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.
For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1l/min using the same mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%