Normoxia Hyperoxia (NBO) is a neuroprotective approach that can be implemented early. NBO is simple and non-invasive and can be used at home or in an ambulance to ensure the shortest possible time after cerebral ischemia occurs. The previous study by the investigators suggested that NBO therapy in the early stage of cerebral ischemia has a neuroprotective effect on ischemic brain injury. Although the neuroprotective effect of NBO has been demonstrated, the optimal duration of treatment for NBO to exert neuroprotective effect is still unclear. Therefore, further discussion of the duration of NBO treatment will contribute to the clinical application of NBO and provide a definite theoretical basis for the treatment of cerebral infarction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
NBO was inhaled as early as possible before revascularization, and inhaled for 1h/2h/4h according to different groups
immediately given oxygen inhalation at a ventilation rate of 1L/ min using a oxygen storage mask and keep giving oxygen for 4 hours.
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Cerebral infarct volume
The infarct volume is evaluated by MRI or CT scan
Time frame: Within 72 hours after randomization
Scores assessed by National Institutes of Health Stroke Scale(NIHSS)
secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 41, higher values indicate more severe deficits)
Time frame: 24hours, 72hours, day7 after randomization
The proportion of good prognosis
the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death;with higher scores indicating more severe disability);The ratio of 0 to 2;
Time frame: 90 ± 10 days after randomization
neurological function improvement rate
NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);
Time frame: Time Frame: 24 ± 6 hours
modified Rankin Scale score (mRS) score
secondary clinical efficacy endpoint; the mRs is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability,and 6=death)
Time frame: 30 ± 7 days, 90 ± 10 days after randomization;
Vascular recanalization rate
secondary imaging efficacy endpoint; Extended Treatment In Cerebral Ischemia (eTICI);The eTICI is an ordinal hierarchical scale ranging from 0 to 3, with higher scores indicating better antegrade reperfusion of the previously occluded target artery ischemic territory; eTICI 2B or 3 are defined as successful recanalization;
Time frame: Time Frame: 4 hours ± 15 minutes
blood biomarkers : occludin(ng/ml), MMP-9(ng/ml), S100B(ng/ml),NSE(ng/ml),GFAP(ng/ml),PGP9.5(ng/ml),etc
Biomarkers for evaluation of BBB damage , brain injury and inflammation,etc:
Time frame: 24 ± 6 hours, 72 ± 24 hours
Incidence of oxygen-related adverse events
Including Headache, dizziness, nausea, vomiting, chest tightness, shortness of breath, cough,etc;
Time frame: 24 ± 6 hours,
Incidence of neurologic deterioration;
NIHSS score increased by more than 4 points);the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits);clinical safety endpoint;
Time frame: 24 ± 6 hours;
Incidence of Symptomatic Intracerebral Hemorrhage
imaging safety endpoints;Deterioration in NIHSS score of ≥4 points within 24 hours;per ECASS III definition and per Heidelberg bleeding classification
Time frame: 24± 12 hours hours after randomization
Incidence of any intracranial hemorrhage
imaging safety endpoints;per ECASS III definition and per Heidelberg bleeding classification
Time frame: 24± 12 hours hours after randomization
all-cause death rate
clinical safety endpoint; Ratio of total deaths from all causes to all enrollments
Time frame: 90 ± 10 days after randomization
Incidence of adverse events
clinical safety endpoint;
Time frame: 90 ± 10 days after randomization
Incidence of surgery-related complications
clinical safety endpoint;
Time frame: 24± 12 hours hours after randomization
stroke related death rate
clinical safety endpoint; Stroke-related deaths as a proportion of all participants
Time frame: 90 ± 10 days after randomization;
Vital signs:respiration(times/min)
clinical safety endpoint;
Time frame: 0 hours, 2 hours, 4 hours after randomization;
Vital signs:heart rate: (times/min)
clinical safety endpoint;
Time frame: 0 hours, 2 hours, 4 hours after randomization;
Vital signs:blood pressure(mmHg)
clinical safety endpoint;
Time frame: 0 hours, 2 hours, 4 hours after randomization;
Vital signs:oxygen saturation (%)
clinical safety endpoint;
Time frame: 0 hours, 2 hours, 4 hours after randomization;
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